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Displaying 1 - 200 of 254
Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Currently Recruiting
We are interested in learning more about these diseases and how to treat them. Our research program is conducting several studies including: a study to learn if treatment with a drug named dupilumab can help reduce asthma attacks in children, a study to observe a specific type of irritation in the lungs and how it relates to asthma symptoms, and more! If…
Condition: Pediatrics
Investigator: Lisa Eisler, MD
Status: Currently Recruiting
We are studying the effects or iron supplementation in patients undergoing surgery for scoliosis. If you are scheduled or are planning to schedule a scoliosis surgery, please contact us to determine eligibility.
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Currently Recruiting
Many patients with breast cancer, who also take medicine to prevent heart disease such as a blood pressure medicine or a cholesterol medicine, experience frustration with the large number and difficult scheduling of their medications, known as pill burden. This study will help us find out how much pill burden exists in subjects with cancer at various stages…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at…
Condition: Cancer / Breast Cancer
Investigator: Claire Sathe, MD
Status: Currently Recruiting
Many patients with breast cancer, who also take medicine to prevent heart disease such as a blood pressure medicine or a cholesterol medicine, experience frustration with the large number and difficult scheduling of their medications, known as pill burden. This study will help us find out how much pill burden exists in subjects with cancer at various stages…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this study is to find out whether zanidatamab combined with physician's choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) is safe and improves on the clinical benefit when compared to trastuzumab in combination with physician's choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or…
Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Each year more than 1,000 babies in the United States are born with a Congenital Diaphragmatic Hernia (CDH). For the majority of these babies, the cause of the CDH is unknown. The DHREAMS (Diaphragmatic Hernia Research & Exploration; Advancing Molecular Science) study was created to improve the understanding of the molecular genetic basis of CDH. This…
Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Currently Recruiting
The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
Condition: Pediatrics / Child and Adolescent Health
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We know that puberty is a major time of change! Adolescents develop new decision-making skills and independence. It is possible that some of these changes are due to the hormonal changes during puberty. One of the ways we treat transgender and gender non-conforming teens is to suppress or "block" puberty. We know that this is a safe thing to do…
Condition: Pediatrics / Child and Adolescent Health
Investigator: Lisa Eisler, MD
Status: Currently Recruiting
We are studying the effects of iron supplementation in patients undergoing surgery for scoliosis. If you are scheduled or are planning to schedule a scoliosis surgery in greater than 3 months, please contact us to determine eligibility.
Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
Condition: Pediatrics
Investigator: Vidhu Thaker, MD
Status: Currently Recruiting
We will enroll children with severe early onset obesity (BMI 99th percentile) diagnosed prior to 6years of age or other endocrine disorders. We will ask questions about their health, eating behavior and perform a brief physical examination. We will collect saliva or blood to perform genetic testing. We will also invite family members to participate in the…
Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study will enroll with children, adolescents and young adults that are less than 22 years old that have returned or 'relapsed' acute myeloid leukemia (AML) diagnoses. Within this group, the study is also targeting those are also unable to receive additional chemotherapy treatments containing anthracycline, which is a type of antibiotic that…
Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This is a phase 1 study for participants with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or juvenile myelomonocytic leukemia (JMML) diagnosis. This study will observe the safety, side effects, and best dose of Imetelstat as an investigational drug, or drug that is not approved by the Food and Drug Administration (FDA…
Condition: Pediatrics
Investigator: Robin Goland, MD
Status: Currently Recruiting
A future without Type 1 Diabetes (T1D) starts with you. Get screened! Thanks in large part to T1D family members, we understand T1D as a disease that progresses in three distinct stages. This new definition in conjunction with TrialNet's Pathway to Prevention screening, allows for earlier detection and intervention.
Condition: Pediatrics
Investigator: Ashley Blanchard, MD
Status: Currently Recruiting
The purpose of the study is to study how to make the home safer for youth at risk of suicide. Our goal is to learn how to better help families whose children are seen in the emergency room for self-injury or suicidal thoughts or actions.
Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
Condition: Cancer / Breast Cancer
Investigator: Rochelle Mendonca, PhD
Status: Currently Recruiting
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Currently Recruiting
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Currently Recruiting
You are being asked to participate in this study because you have indolent SM (ISM) or because you have Monoclonal mast cell activation syndrome (mMCAS). Currently, there are no available targeted therapies for patients with ISM or mMCAS. The study will test the drug BLU-263. BLU-263 is a new study drug that is being developed for treating people like you,…
Condition: Cancer / Leukemia
Investigator: Andrew Lipsky, MD
Status: Currently Recruiting
This research is being done because Richter's transformation, which is a life-threatening complication of chronic lymphocytic lymphoma (CLL), and is associated with poor overall survival rate. The study drug administration is a combination of the investigational drug, Polatuzumab vedotin, in combination with Rituximab, Etoposide, Prednisone,…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Currently Recruiting
You are being asked to participate in this study because you have Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and we are testing the study drugs, SEA-CD70, to find out what its side effects are and to see if the study drug is safe for people with these types of cancer are testing to see if SEA-CD70 is safe for people, and its side effects…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a…
Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Currently Recruiting
The purpose of this study is to determine if overall survival of patients monitored with serum tumor marker direct disease monitoring (STMDDM) is as good as the overall survival of patients monitored with the usual care.
Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this research, we want to learn more about how to improve care for children who are listed for or who have received a liver transplant. The goal of this research is to look at how different hospitals treat these children and to look at their outcomes to help improve care, decrease complications, shorten length of hospital stay, reduce hospital re-…
Condition: Pediatrics
Investigator: Liat Itzhaky, PhD
Status: Currently Recruiting
Your child is invited to participate in a research study. Participation in the study includes one meeting at Washington Heights. Results from this study will assist in modifying an existing behavioral intervention to fit children of this age. For more details, please contact Dr. Liat Itzhaky at 646-774-7634 or e-mail: li2185@cumc.columbia.edu. Participants…
Condition: Pediatrics
Investigator: Rachel Marsh, PhD
Status: Currently Recruiting
To learn more, click the blue box "Do you qualify" and our study team will contact you. This research study will examine how an iPad-based cognitive training game combined with cognitive behavioral therapy (CBT) helps children with excessive worries and related repetitive behaviors (obsessive compulsive disorder). After completing the training,…
Condition: Pediatrics
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center ( TCRC).
Condition: Pediatrics
Investigator: Randy Auerbach, PhD
Status: Currently Recruiting
We are recruiting depressed adolescents ages 13-18 years. As a participant in our study, we will: (1) interview your child about current and past thoughts, feelings, and behaviors, (2) teach your child mindfulness strategies, (3) collect brain activity data with MRI (non-invasive) while your child practices mindfulness, and (4) send short surveys to your…
Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
A Study for Patients with Advanced Melanoma, Solid Tumors or Lymphoma Using Study Drug Pembrolizumab
Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
The purpose of this study is to determine if a study drug called pembrolizumab is safe and effective in the treatment of children and adolescents who have advanced melanoma, or advanced, relapsed, or refractory PD-L1 positive malignant solid tumor or other lymphoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL), advanced, relapsed or refractory…
Condition: Pediatrics
Investigator: Lawrence Lustig, MD
Status: Currently Recruiting
The CHORD clinical trial, sponsored by Decibel Therapeutics, is looking at the use of the gene therapy DB-OTO for children born with hearing loss related to changes in the OTOF gene. The goal of this trial is to assess different doses of DB-OTO to find out if it is safe, well-tolerated, and its effect on improving hearing. DB-OTO is a gene therapy that has…
Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Study examining the genetic causes of birth defects
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA.…
Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Currently Recruiting
The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100…
Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We are doing this research study to find out what happens to children who are overweight and how the things we recommend as a part of routine clinical care affect your child. The purpose of this study is to understand what happens to children as a result of being overweight, to link these outcomes to specific clinical measures, and to determine how…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the use of the Addinex device, a time-release medication dispenser designed to assist with medication adherence, in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery.
Condition: Pediatrics
Investigator: Martha Welch, MD
Status: Closed
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). This study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii…
Condition: Pediatrics
Investigator: Maria Kwok, MD, MPH
Status: Closed
What's fast-moving, all-encompassing, and plays no favorites? Sepsis, an indiscriminate systemic condition that escalates so rapidly, national guidelines recommend treatment begin within 20 minutes of arrival to the emergency department. Crystalloid resuscitation with normal saline or balanced fluids (including lactated Ringers and Plasma-Lyte) is the…
Condition: Pediatrics
Investigator: Jennifer Bain, MD
Status: Closed
This is a Phase IIA Multicenter, open-label, 12-week study to investigate the pharmacokinetics and safety and to provide proof of mechanism of the drug, Alogabat (RO7017773) in children and adolescents aged 5-17 years old with Angelman Syndrome with the deletion genotype.
Condition: Pediatrics
Investigator: Mishaela Rubin, MD
Status: Closed
We are looking for children between the ages of 8-14 with Type 1 diabetes and without Type 1 diabetes who are interested to participate on a research study to find out how bones are affected in children and adolescents with Type 1 diabetes as compared to people without Type 1 diabetes.
Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing your cancer from returning? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is…
Condition: Cancer / Leukemia
Investigator: Markus Mapara, MD
Status: Closed
The purpose of the study is to learn if a transplant using bone marrow recovered from deceased organ and tissue donors is safe and effective in patients undergoing bone marrow transplant (BMT). This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard of care for transplant. Bone marrow cells…
Condition: Cancer / Breast Cancer
Investigator: Lauren Houghton, PhD
Status: Closed
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The Young, Empowered & Strong (YES) study is opened to women who were diagnosed with breast cancer between the ages of 15 and 39 years. Women will need to be within 3 years of the end of early active treatment (e.g. surgery, chemotherapy not including HER2-directed therapy, radiation), and have no know evidence of breast cancer recurrence. The study…
Condition: Pediatrics / Cancer
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
Condition: Pediatrics
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or leukemia of mixed lineage (the leukemia cells cannot be classified as AML or ALL or where both types of AML and ALL cells are present). Because you have already received standard therapy that is no longer helping, or there is…
Condition: Pediatrics
Investigator: Brooke Aggarwal, EdD, MS, FAHA
Status: Closed
High school students ages 14-18 and their parent(s) may be eligible to participate in a 12-week (consisting of a 6-week pre-pilot and 6-week pilot) sleep health education program.
Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 study of a drug called uproleselan. We are testing new experimental drugs such as uproleselan in the hopes of finding a treatment that may be effective against acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that has come back or that has not responded to standard therapy. This study looks at how well…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). Panzyga is a study drug administered via injection into the vein, which contains human antibodies also called immunoglobulins. It is manufactured by Octapharma. Your participation in this clinical…
Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
This study is being done to identify the best outcomes for hematopoietic cell transplantation (HCT) or other treatment (enzyme replacement or gene therapy), which is life-saving therapy for children with SCID (severe combined immunodeficiency), leaky SCID, Omenn syndrome and reticular dysgenesis.
Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to create a decision-making tool that will help doctors decide which children with headaches require a CT ("CAT scan," "computed tomography") or MRI scan of their head as part of their emergency department care.
Condition: Pediatrics / Down Syndrome
Investigator: Michael DiLorenzo, MD
Status: Closed
Down syndrome (DS) occurs in roughly 1 out of 700 births in the U.S. Half of all children with Down syndrome have congenital heart disease (CHD), often requiring corrective heart surgery. Even though CHD in children without DS is known to be associated with developmental problems, few studies have explored how CHD can affect the development and behavior of…
Condition: Pediatrics
Investigator: Ashwini Rao, EdD, OTR
Status: Closed
Child to Adult Neurodevelopment in Gene Expanded Huntingtons Disease (ChANGE HD) HD has long been considered an adult-onset disease. However, research has shown that brain changes are evident before motor symptoms begin. In fact, the gene responsible for HD plays a role in brain development and is present throughout the lifespan. With gene knockdown therapy…
Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
Condition: Pediatrics
Investigator: Dana Goldner, MD
Status: Closed
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
Condition: Cancer / Leukemia
Investigator: Markus Mapara, MD
Status: Closed
You are being asked to take part in this study because you have acute myeloid leukemia (AML). Vor Biopharma, is a company that is testing a possible new treatment for AML. This possible new treatment, is VOR33. In this study, your blood-forming stem cells will be genetically modified to become VOR33. VOR33 has not been approved by the Food and Drug…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the effects of etavopivat, good and bad, in individuals with myelodysplastic syndrome (MDS).
Condition: Cancer / Childhood Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
Condition: Cancer / Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The study is being done to answer the following question: How can we best help women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) and their healthcare providers make informed decisions about whether to take breast cancer risk-reducing pills (drugs to slow or prevent breast cancer from developing)? Participants in this study will learn…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to test the safety and effectiveness of an investigational treatment called pirtobrutinib (LOXO-305) plus venetoclax and rituximab (PVR) versus venetoclax and rituximab (VR). Pirtobrutinib is an investigational (or experimental) drug that may treat your Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to find out what is the best dose of intranasal midazolam for children to help them stay calm and hold still while they are having a cut in their skin fixed.
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment…
Condition: Pediatrics
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced…
Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to find out whether people who are currently receiving treatment with venetoclax can stop treatment and remain off-treatment for at least 12 months, if they are free of residual disease (MRD- negative) when they stop treatment.
Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin, vincristine and PEG-…
Condition: Pediatrics
Investigator: Cindy Neunert, MD
Status: Closed
The purpose of this study is to investigate the safety and effectiveness of eltrombopag (investigational drug) in treating children and adolescents with newly-diagnosed immune thrombocytopenia (ITP), which is a rare blood disorder.
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to answer the following question: How does the combination of copanlisib and eribulin compare to eribulin alone to lengthen the time you can live with your metastatic triple-negative breast cancer without your cancer getting worse? We are doing this study because we want to find out if this approach is better or worse than the usual…
Decreasing Chemotherapy for HER2 Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Can participants with HER2-positive breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after 12 weeks of chemotherapy and two HER-targeted therapies eliminate further chemotherapy after surgery? This would be a decrease in the total number of…
Condition: Pediatrics / Cardiology
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to find the highest dose of STK-009 that is safe in combination with a dose of SYNCAR-001 and to learn what side effects are experienced in people with certain lymphomas or leukemias. This study will also evaluate how much SYNCAR-001 and STK-009 is in your blood at various times, whether your immune system becomes activated,…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to see how safe an investigational drug, LY3484356 is and how well it will work to help people with estrogen receptor-positive (ER+), HER2 negative (HER2-) locally advanced or metastatic breast cancer previously treated with endocrine therapy. The main reason for you to take part in this study is not to treat you for your condition…
Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to evaluate the safety and efficacy of venetoclax and azacitidine compared to Best Supportive Care in patients with Acute Myeloid Leukemia (AML) after an allogeneic stem cell transplant (SCT). This is the first randomized study comparing venetoclax in combination with azacitidine versus best supportive care in subjects with AML…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have a myeloproliferative neoplasm (MPN) that has transformed to accelerated or blast phase. MPN is a group of diseases in which the bone marrow makes too many blood cells. The different types of MPN are myelofibrosis (MF), essential thrombocythemia (ET), or polycythemia vera (PV). Over time,…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have been diagnosed with a blood cancer called Acute Myeloid Leukemia (AML) with or suspected to have a specific gene mutation (TP53 mutation) for which you have not received any prior AML treatment. Tumor protein p53 (TP53) is a gene that codes for a tumor suppressor protein, which is normally…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to evaluate if the study drug, niraparib will help patients delay or prevent their breast cancer from returning. This study will compare niraparib to placebo in study participants who have been treated for breast cancer and were then found to have breast cancer ctDNA (Circulating tumor DNA (ctDNA) is found in the bloodstream and…
Condition: Pediatrics / Child and Adolescent Health
Investigator: Maria Kwok, MD, MPH
Status: Closed
The purpose of this study is to evaluate the effectiveness and adverse reactions of the various types of noninvasive positive pressure supportive use in the management of children with moderate to severe acute asthma exacerbation.
Study of Olanzapine in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant (HSCT)
Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
This research study is to find out whether adding olanzapine to standard antiemetics will be helpful in controlling chemotherapy-induced vomiting (CINV) in children receiving high-dose cyclophosphamide for Blood/Bone Marrow Transplant (BMT) conditioning.
Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Closed
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of the study is to determine an appropriate dose of KRT-232 in combination TL-895 or KRT-232 alone for treatment of myelofibrosis (MF). There are 2 parts planned for this study, the Phase 1b that will test different doses of TL-895 given with KRT-232 and it will also test KRT-232 alone, to identify the recommended dose for Phase 2. The Phase 2 (…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to determine the optimal dose of oral CGT9486 in patients with Advanced Systemic Mastocytosis (AdvSM) and to determine the efficacy of CGT9486 at the selected optimal dose in patients with Advanced Systemic Mastocytosis (AdvSM). This includes Aggressive Systemic Mastocytosis, Advanced Systemic Mastocytosis with an Associated…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to determine the effectiveness of the study treatment- bendamustine and rituximab (BR) followed by venetoclax for 12 months. The combination of the drugs bendamustine and rituximab is a commonly used treatment for your disease. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. With this…
Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
This study is being done to answer the following question: How can we best help patients and their clinicians make decisions about breast cancer treatment (surgery and other treatments, like radiation and chemotherapy)? We are doing this study because we want to better understand how to support patients in making decisions about breast cancer treatment. We…
Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
Patients who will be receiving immune effector cell (IEC) therapy for the treatment of their cancer (leukemia) are being asked to participate in this study. IEC can produce a harmful side effect called Cytokine Release Syndrome (CRS). CRS involves a release of a large amount of proteins into the bloodstream. This may cause changes in blood pressure and…
Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to compare usual lymph node surgery to an added procedure during the surgery to help surgeons see the lymph node system better. During usual surgery, the lymph node system may be disrupted, which can cause swelling in the arm. This research study will use a new lymph node surgery technique to look at how fluid drains through the…
Condition: Pediatrics
Investigator: Jin Hee Kim, MD
Status: Closed
In this research study we want to learn more about a potential new therapy for pain associated with endometriosis. We want to determine if a non-hormonal medication, cabergoline, will help patients with endometriosis. Cabergoline is a medication that is approved by the Food and Drug Administration (FDA) for treatment of other medical conditions. In this…
Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to examine whether removing some of the lymph nodes from the armpit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the armpit removed during breast surgery followed with radiation(standard of care). Patients will be randomized to either of…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with MDS (Myelodysplastic Syndrome). Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to find out, good and/or bad, the effects of the investigational drug, Imprime PGG, when given together with pembrolizumab (also known as Keytruda, a type of checkpoint inhibitor) in the treatment of your type of cancer. Checkpoint inhibitors are a type of immunotherapy that block immune checkpoint proteins from binding with…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This is a first-in-human, phase 1/1b, open-label study of single-agent PMD-026 conducted in participants with metastatic breast cancer. PMD-026 will initially be administered orally on a once-daily schedule. Part 1 of the study will evaluate PMD-026 in participants with metastatic breast cancer that have not responded to treatment, which may involve…
Condition: Pediatrics
Investigator: Doron Amsalem, MD
Status: Closed
We are conducting a research study to explore discrimination around depression and barriers to care in youth ages 14-18. We will use what we learn to create videos to reduce such discrimination. Parental permission is required for this study. Adolescents (ages 14-18) will participate in an individual interview that will be approximately 45 minutes long. We…
Condition: Cancer / Leukemia
Investigator: Andrew Lipsky, MD
Status: Closed
The purpose of this study is to assess the safety, effectiveness, pharmacokinetic (PK how long the drug is in your body and how it is metabolized) and pharmacodynamics (PD where does the drug go in your body and what is its biological effect) of the study drug, GFH009, in patients with relapsed or refractory hematologic malignancies including acute myeloid…
Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to 21 years of age. This study consists in two-phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or…
Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of giving anastrozole, palbociclib, trastuzumab, and pertuzumab to women with hormone receptor-positive, HER2-positive metastatic breast cancer. This combination of medications represents an all-biologic approach and avoids chemotherapy as first-line treatment of this disease.
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this clinical research study is to evaluate the safety (any good or bad effects) of CYNK-001 and to assess the effects of CYNK-001 on your Acute Myeloid Leukemia (AML). Also, the study plans to determine the maximum tolerated dose (highest safe dose) of CYNK-001 and assess whether CYNK-001 can eliminate your residual (leftover) disease.…
Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of Vincristine Sulfate Liposome Injection (Marqibo) in combination with UK ALL R3 induction chemotherapy. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) who have relapsed…
Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the highest dose of Flotetuzumab that can be given safely to patients who have a certain type of leukemia called Acute Myeloid Leukemia (AML) that has relapsed (has come back after treatment) or is refractory (never responded to treatment). Flotetuzumab is an experimental treatment that works by targeting certain…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Nobuko Hijiya, MD
Status: Closed
We are testing new experimental drugs such as selinexor in the hopes of finding a treatment that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: To find the highest safe dose of selinexor that can be given without causing severe side effects; To learn what kind of side effects…
Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to determine whether there is clinical benefit to continue therapy beyondprogression for metastatic or unresectable breast cancer. The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called Cyclin Dependent Kinase 4 and 6 inhibitors, which…
Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The purpose of this study is to see how effective and safe the drug maralixibat is when compared to placebo in infants with biliary atresia who have had Kasai surgery within 3 weeks before participation. This is a 26-week, multicenter, double-blind, placebo-controlled, randomized parallel-group study, followed by an open-label extension (OLE). Approximately…
Condition: Pediatrics / Cancer
Investigator: Gary Schwartz, MD
Status: Closed
The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the…
Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
Condition: Cancer / Breast Cancer
Investigator: Diana Martinez, MD
Status: Closed
Paclitaxel is frequently used to treat breast cancer, but it can also cause neuropathy where the nerves of the hands and feet stop working properly. The symptoms of neuropathy can include pain, numbness, and difficulty with everyday activities like walking or typing. Paclitaxel-induced neuropathy is common and there are few treatment options. Our study will…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
This research study involves receiving an experimental drug referred to as ZN-c5. This is the first study in humans using ZN-c5. The purpose of this research study is to test the safety of ZN-c5 at different dose levels. This study is designed to find out what effects, good and/or bad, ZN-c5 has on participants with breast cancer. Participants in both…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This research study is evaluating an investigational drug, called cirmtuzumab, in combination with astandard drug, called ibrutinib (Imbruvica), as a possible treatment for patients with CLL/SLL or MCL. All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of…
Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The social determinants of health have a large impact on health. We have previously demonstrated that an index of neighborhood socioeconomic deprivation was associated with an increased risk of medication non-adherence in children after liver transplant and an increased risk of graft failure and death in children after transplant. The present proposal seeks…
Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to identify if blood sugar elevations during chemotherapy may be related to the development of side effects from chemotherapy. This study will help us find out if blood sugar goes up during the course of chemotherapy, and if so, for the amount of time the blood sugar is elevated after a chemotherapy treatment. Results of this…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse…
Condition: Pediatrics / Cancer
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and young adults patient with relapsed (has returned) and progressive medulloblastoma (brain tumor). This study is being done to find out if bevacizumab can be safely given in combination with five study drugs given by mouth, thalidomide, fenofibrate, celecoxib and alternating every…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to find out what dose of pacritinib is safest and works best for participants. Pacritinib is an experimental drug, which is a drug that is being tested and is not currently approved by the Food and Drug Administration (FDA) in the US. The study will be conducted at about 85 study clinics in North America, Europe, Israel and…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to: Test if the lifespan of study participants is increased when uproleselan is added to standard chemotherapy medicines compared to standard chemotherapy alone; test if the number of study participants achieving disease remission is increased when uproleselan is added to standard chemotherapy medicines compared to standard…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare any good and bad effects of using olaparib and atezolizumab in combination compared to olaparib alone. The use of olaparib alone or in combination with atezolizumab could shrink your cancer but could also cause side effects. This study will allow the researchers to know whether the combination approach is better, the…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The purpose of this study is to determine whether treatment with sacituzumab govitecan could provide a better response and improve survival (the amount of time you live without your cancer growing) than other forms of cancer treatment (either Eribulin, Capecitabine, Gemcitabine, Vinorelbine).
Condition: Pediatrics
Investigator: Monica Bhatia, MD
Status: Closed
The overall purpose of this research is to treat diseases that are not cancer but are improved by bone marrow transplantation with mild and safer chemotherapy as pretransplant conditioning. This treatment is chosen because it is milder and is likely to have fewer long and short term side effects unlike older chemotherapy and radiation treatments. Yet, it…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see how safe investigational drug, LY2835219 is and how well it will work to help people with advanced hormone receptor (HR) positive, HER2 negative breast cancer. This study will investigate whether the combination of LY2835219 plus fulvestrant improves outcomes compared to fulvestrant alone for women with a certain type of…
Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The main purposes of this study are to: 1) understand the safety of atezolizumab given in combination with Hu5F9-G4 and 2) understand the way the body processes atezolizumab and Hu5F9-G4 (pharmacokinetics). This study will also be testing if the combination therapy is effective at treating relapsed or refractory acute myeloid leukemia (R/R AML).…
Condition: Pediatrics / Cancer
Investigator: Maria Sulis, MD
Status: Closed
The purpose of this study is to determine the effectiveness and safety of the study drug moxetumomab pasudotox in treating children with relapsed or refractory pALL or Lymphoblastic Lymphoma of B-cell origin. Moxetumomab pasudotox is made up of two parts: 1) a modified mouse antibody that attaches to a protein from the immune system, called CD22, which can…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to test the safety and effectiveness of an experimental medication, FT-2102, in the treatment of acute myeloid leukemia or myelodysplastic syndrome. Patients will receive either FT-2102 alone or in combination with cytarabine or azacitidine, an approved drug commonly used in the treatment of AML and MDS. Subjects will remain on…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This is a Phase 1 multicenter study of a drug called ABI-009 (nab-Rapamycin) in combination withtemozolomide and irinotecan in children and young adults with solid tumors (including CNS tumors)which have come back or have not responded to standard therapy. The study is considered experimental because ABI-009 (nab-Rapamycin) is not approved by the United…
Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of this study is to measure the effectiveness and safety of an investigational drug called "alovicidib" in combination with cytarabine and daunorubicin in the treatment of AML. Investigational means that this drug has not been approved by the FDA. Cytarabine and daunorubicin are both standard of care treatments for patients with AML.…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the safety, and effectiveness of ABT-199 in combination with decitabine and ABT-199 in combination with azacitidine in subjects who have not been treated for their AML. In addition, substances (biomarkers) found in the blood and bone marrow that may indicate the effects or progress of the leukemia and the activity of…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine whether the combination of study drugs Ruxolitinib plusTrastuzumab is safe and effective in stopping breast tumor growth in patients with HER2 positivemetastatic breast tumors who have already received Trastuzumab. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer.
Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
This is a phase I, multicenter, dose escalation study of MK-1775 in combination with radiation. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG). MK-1775 is an oral…
Condition: Cancer / Breast Cancer
Investigator: Margaret Chen-Seetoo, MD
Status: Closed
The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions in Chinese patients. The Agendia Breast Cancer Suite includes MammaPrint, TargetPrint, BluePrint, and TheraPrint which are…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study, which involves research, is to determine if giving an experimental drug called acalabrutinib in combination with venetoclax with and without obinutuzumab is safe and effective for treating people with CLL compared to a combination of bendamustine and rituximab (BR) or a combination of Fludarabine, Cyclophosphamide and Rituximab (…
Condition: Pediatrics
Investigator: Ali Mencin, MD
Status: Closed
This study is evaluating an investigational medication to see if it is safe and if it works well in children andadolescents who have mild to moderate ulcerative colitis (UC) or are in remission. Ulcerative colitis (UC) is a chronic disease of the last section of the intestine, which is also known as the colon. If you have UC, the lining of your colon…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to find out more about how the study drug called entrectinib will be used in children, adolescents and young adults with treatment-resistant solid tumor in brain or body. This is a phase 1/1b study, divided into a dose escalation portion (different dose will be tested) and a dose expansion portion (one dose will be tested) in…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to provide samples for biomarker testing for the different MPD-RC treatment studies. As part of the treatment study you currently participating in, this is an additional research study in which you we will ask for you to donate blood and/or bone marrow samples, two nail clippings, and buccal (cheek) swab. In order to…
Condition: Cancer / Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in young adults with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has either come back or has not responded to the standard therapy. Pevonedistat works by blocking some of the enzymes that are needed for cell growth.
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study is for patients with Richter's transformation (RT). The purpose of this study is to see if a new type of investigational drug called PNT2258 that may be effective in blocking the "on" signal to cancer cells, eventually causing them to die. We are trying to see if PNT2258 provides evidence of anti-tumor effect by measuring what…
Study of Safety and Efficacy of Eribulin in Combination with Pembrolizumab in Breast Cancer Patients
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to evaluate the effectiveness and safety of eribulin mesylate (eribulin) incombination with pembrolizumab in metastatic (spread of cancer from one part of body to another) triple-negative breast cancer (mTNBC).
Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Closed
The Breathe Easy Early ORBEX Study is a three -year study to identify if a daily capsule of Broncho-Vaxom may help prevent or delay young children from developing wheezing or asthma- like symptoms. Other studies have found that Broncho-Vaxom can help prevent upper respiratory infections and stimulate immune defenses, and has been safely and effectively used…
Condition: Cancer / Leukemia
Investigator: Alice Lee, MD
Status: Closed
This study is for children and teens who have been diagnosed with Acute Myeloid Leukemia (AML). AML is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood cells called blasts. These blast cells crowd out the normal cells of the bone…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to find out more about how the study drug called talimogene laherparepvec will be used in children/adolescents/young adults with advanced solid tumors not involving the central nervous system that are available for direct injection. This is a phase 1 study, multicenter, open-label study, that means all subject enrolled in the…
Condition: Pediatrics
Investigator: Leonardo Liberman, MD
Status: Closed
The purpose of this study is to investigate how mothers with babies with congenital heart disease feel about breastfeeding. We will ask you to fill out a survey while you are in the hospital at around the time of delivery and another survey approximately three months later to see how you feel about breastfeeding. In addition to the survey data, the study…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to find if PTC299 is safe to treat people with relapsed/refractory acute myeloid leukemia (AML) as well to determine the dose of PTC299 that can be given without causing severe side effects. AML is a cancer of the blood and bone marrow (spongy tissue inside bones where blood cells are made). PTC299 is being developed to…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Julia Glade Bender, MD
Status: Closed
The purpose of this study is to examine the effectiveness and tolerability of a study drug called PF-02341066. Additional goals of this study are to learn how the body handles the study drug as well as determine whether or not PF-02341066 is a beneficial treatment for your tumor This study is for children with a recurrent or progressive tumor or lymphoma…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to find the dose of imetelstat that best treats myelofibrosis. (A doseis a measured amount of a drug taken at one time.) The effects of imetelstat on myelofibrosis as well as any side effects will be explored.
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The goal of this study is to determine if ribociclib in combination with letrozole as neoadjuvant endocrine therapy increases the proportion of women with PEPI score of 0 at surgery, compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy. The PEPI score measures the risk of breast cancer…
Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Closed
Research funded by the NIH is being done to learn if an asthma medication, given along with standard asthma care, makes children less likely to have asthma attacks.
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to compare the safety, tolerability, and effectiveness of ruxolitinib, an investigational drug, compared to anagrelide, an FDA approved drug. Investigational means that the study drug has not been approved by the FDA for treatment of ET. Patients will be assigned to one of two groups. Group A will receive ruxolitinib and placebo…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to evaluate how well the study drug ABT-199 works and safety of ABT-199 in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back (relapsed) after treatment or no response (refractory) to treatment with B-cell receptor signaling pathway inhibitor therapy, namely Ibrutinib and/or Idelalisib. In addition,…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without the subjects cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney…
Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this research study is to determine if the experimental drug balixafortide combined with eribulin is well tolerated and more effective for treating breast cancer compared with eribulin given alone. Balixafortide (POL6326) interacts with proteins called CXCR4 receptors which may directly suppress tumor growth through disruption of signaling…
Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Closed
Your child has been asked to participate in this study because he/she may have or has growth hormone deficiency (i.e. not enough growth hormone in his/her body) and your doctor has already determined that your child may be suitable to be screened for this study. OPKO Biologics Ltd., the Sponsor of this clinical study, has developed an…
Condition: Cancer / Breast Cancer
Investigator: Jeffery Ascherman, MD
Status: Closed
The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study…
Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The main purpose of this research study is to investigate if a drug called Vedolizumab is safe and effective in preventing acute graft-versus-host disease (attack of donor cells on recipient healthy organs after transplant) of the gut in comparison to placebo (dummy drug). This will be studied in patients undergoing Allogeneic Hematopoietic Stem Cell…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to learn what kind of side effects nivolumab as a single agent and nivolumab in combination with ipilimumab can cause and if these treatments are beneficial for solid tumors. Nivolumab (Dose Level 1) will be given as an intravenous infusion every 14 days of a 28 day cycle. If Dose Level 1 is not tolerable, then it will be…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to test the safety of the combination of the experimental drugs called atezolizumab and guadecitabine (not yet approved by the U.S. Food and Drug Administration FDA or any other regulatory authority outside the United States) to find out what effects, good or bad, the combination of atezolizumab and guadecitabine has on patients…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.
Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This is a phase 1/2 multicenter study of AZD1775 (MK-1775) that will be given in combination with irinotecan. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with solid tumors which have come back or have not responded to standard…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The overall purpose of this part of the study is to determine the best dose of JCAR017 for treating adult participants with relapsed or refractory B-cell Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Lymphoma (SLL) and to understand the side effects that participants with your disease may have when they are treated with JCAR017.
Condition: Cancer / Leukemia
Investigator: Todd Rosenblat, MD
Status: Closed
The purpose of the study is to test how effective and safe the study drug SGI-110 is compared with current standard treatment for AML. The study drug, SGI-110, is changed in the body into a compound called decitabine. Decitabine is an approved drug in the US for treatment of patients with myelodysplastic syndrome (MDS) and in Europe for treatment of…
Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of temsirolimus in combination with etoposide and cyclophosphamide. The study treatment is considered experimental because it is not approved by the Unites States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) and non-Hodgkins lymphoma (NHL) who have relapsed. The…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to find out what side effects (unwanted effects) are caused in patients with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in…
Condition: Pediatrics
Investigator: Sharon Oberfield, MD
Status: Closed
We are recruiting boys between 3-9 years old and girls between 3-8 years old to participate in a research study. Children who would like to participate must be healthy and not showing signs of puberty. The goal of the study is to understand the relationship between early body development, metabolism (sugars and fats processing), and the saliva microbiome (…
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of the study is to see if a medicine called gilteritinib/ASP2215 given in combination with atezolizumab is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene. Some AML patients have a mutation in the gene called FLT3. When patients have a FLT3 mutation, more of the FLT3 protein is on the leukemic cells, or…
Condition: Neuromuscular / Spinal Muscular Atrophy
Investigator: Claudia Chiriboga, MD, MPH
Status: Closed
The purpose of this study is to evaluate the safety, tolerability and effectiveness of a study drug called ISIS-396443 when using it to treat children with later-onset spinal muscular atrophy (SMA). SMA is a neuromuscular disease that causes a degeneration (a breakdown) of the motor neurons in the spinal cord, resulting in a weakening of the muscles in…
Condition: Cancer / Leukemia
Investigator: Richard Carvajal, MD
Status: Closed
This study is for patients with Acute Myeloid Leukemia (AML). The purpose of this study is to determine if decitabine plus JNJ-56022473 can be safely combined and is active for your disease. The study drugs used in this study are JNJ-56022473, an experimental drug and DACOGEN ( also known generic as decitabine), a drug already used to treat your type of…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low…
Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
This is a Phase 1 multicenter study of LY2606368, a CHK1/2 inhibitor, in pediatric patients with refractory solid tumors, including CNS tumors. The study treatment is considered experimental because LY2606368 is not approved by the United States (US) Food and Drug Administration (FDA) for treating pediatric patients with refractory solid tumors, including…
Study of sertraline (Zoloft) with ara-C in combination in patients with acute myeloid leukemia (AML)
Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of the study is to evaluate the safety, tolerability (the effect of the drug on your body), pharmacokinetics (the effect of your body on the drug) and maximum tolerated dose of sertraline in combination with cytosine arabinoside (ara-C, cytarabine) when given to patients with treatment-resistant myeloid leukemia. In addition, the effect of the…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
Tomography (DOT), can help predict how well patients respond to a pre-surgical therapy. This imaging technique uses light to create 3D maps of the blood, fat, and water content of the breast. Based on these measurements taken over 2 time points during therapy (before and after), we will try to determine if this new imaging technique can use early…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The purpose of this study is to determine the effect of different doses of ZN-c5 on levels of hormone (estrogen) receptors in breast cancer and how large that effect is for each dose level. The amount of reduction in hormone receptors may indicate that the drug is doing what it intends to do and how effective it is. The results will help define what an…
Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing T-cells, which cause chronic…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to compare the effects, good and/or bad, of study drug cobimetinib and paclitaxel for patients with metastatic truple-negative breast cancer (mTNBC). In this study, you will receive either a combination of cobimetinib and paclitaxel or placebo (no active medication) and paclitaxel. The study will also evaluate what side effects…
Condition: Neuromuscular / Spinal Muscular Atrophy
Investigator: Darryl De Vivo, MD
Status: Closed
This study is for infants that have been genetically diagnosed with Spinal Muscular Atrophy (SMA) and are currently not showing any signs or symptoms of the disease. The purpose of this study is to see whether ISIS 396443 has any effects (good or bad) on infants with SMA (who do not yet show signs or symptoms of the disease) and to see if ISIS 396443 can…
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study is being done to see how well tolerated the investigational drug TGR-1202 is in comparison to other similar therapeutics agents in treating patients with chronic lymphocytic leukemia (CLL).
Condition: Cancer / Breast Cancer
Investigator: Allison Borowski, MD
Status: Closed
We are currently recruiting women to TMIST, a clinical trial that will help us develop strategies that tailor breast cancer screening to the risks of individual women. This is a screening trial. The purpose of this trial is to determine if tomosynthesis (3-D) mammography detects breast cancer at earlier stage than current method of 2-D digital mammography.
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The main goal of this study is to find out about how duvelisib acts in patients with CLL/SLL who were previously treated with a BTKi (Bruton Tyrosine Kinase inhibitor - commercially available ibrutinib or another investigational BTKi). Duvelisib is an investigational drug, meaning that it is not FDA approved, designed to try to stop cancer growth by…
Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
This is a clinical research study for subjects with Myelofibrosis (Primary, Post-Polycythemia Vera, and Post-Essential Thrombocytopenia) and thrombocytopenia. The purpose of this study is to determine if pacritinib is better at reducing spleen size and a reduction in symptoms than the best available therapy. This is a randomized, controlled study.…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this research study is to determine if using a piece of the patient's residual tumor to develop a model of her cancer in mice that lack an immune system (also called an immune-deficient mouse) could help in determining which additional drugs or compounds to which an individual breast tumor is sensitive. The tumor implanted in the mouse…
Condition: Pediatrics / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
Moving forward in Charcot-Marie-Tooth disease. A clinical research study assessing the safety and effectiveness of an investigational product in people with Charcot-Marie-Tooth (CMT) disease experiencing muscle cramps is now enrolling. Participation is entirely voluntary. Contacting us does not mean that you are required to take part in this study. If you…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
This study is for women with breast cancer who will be undergoing lumbar puncture to evaluate for the presence of leptomeningeal metastasis, a complication in which the cancer spreads to the membranes (meninges) surrounding the brain and spinal cord. This condition is typically diagnosed by examining the cerebrospinal fluid obtained from the lumbar puncture…
A study for children with refractory solid tumors, including CNS tumors using study drug ramucirumab
Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
The goals of this study are to find the highest safe dose of ramucirumab that can be given without causing severe side effects, to learn what kind of side effects ramucirumab can cause, to learn more about the effects of ramucirumab on cells and proteins in the blood and to determine whether ramucirumab is a beneficial treatment for patients with solid…
Condition: Pediatrics / Neuromuscular
Investigator: Darryl De Vivo, MD
Status: Closed
Our clinic is currently participating in the Brave Trial, a clinical research study for Duchenne muscular dystrophy (DMD). This study is being conducted to learn whether a study drug can improve motor functions in boys with DMD. If your child takes part, he'll receive at no cost: study drug or placebo, study-related procedures, reimbursement for…
Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of this research study is to determine the preliminary safety and effectiveness (how well something works) of alvocidib when used after the standard drug decitabine in patients with MDS. The study will also gain information about the PK (the process by which a drug is absorbed, distributed, metabolized and eventually eliminated by the body),…
Condition: Cancer / Pediatric Solid Tumors
Investigator: Julia Glade Bender, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of a study drug called axitinib on treating tumors that have returned (recurrent) or have not responded to standard therapy (refractory). Children will take axitinib twice a day for 28 days (1 cycle). Children may take study drug for up to 24 cycles (2 years).
Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study, which involves research, is to determine if an experimental drug: acalabrutinib is safe and effective in the treatment of this patients with High Risk Chronic Lymphocytic Leukemia (CLL). Acalabrutinib is an investigational drug, which means that it is still being tested in people and has not been approved by government agencies in…
Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
This is a study for patients diagnosed with either breast cancer that is HER-2 positive, or breast cancer that is negative for estrogen, progesterone and HER-2 (triple-negative disease), and whose tumor can be removed by breast-conserving surgery. The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging)…
Condition: Pediatrics
Investigator: Wei Shen, MD
Status: Closed
This is a study of body changes that take place in teenagers who undergo bariatric surgery as a treatment for obesity and obesity-related conditions. Changes will be measured by serial MRI andmetabolomic profiling.
Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The main purpose of this study is to see how effective an investigational new drug (tipifarnib, the study drug) is to treat myelodysplastic syndrome (MDS). "Investigational" means that tipifarnib has not yet been approved by regulatory authorities such as the United States Food and Drug Administration (FDA) for use outside of clinical trials. You…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This study examines diffuse optical tomography (DOT) as a way to monitor the progress of the breast cancer therapy. Specifically, it looks at DOTs ability to detect non-responders early in treatment and then adjust the therapy to improve response and overall survival. DOT is favorable to more conventional forms of cancer monitoring, such as physical exams,…
Condition: Pediatrics
Investigator: Rakesh Sahni, MD
Status: Closed
The purpose of this study is to see if the use of bubble nasal continuous positive airway pressure (NCPAP) at a pressure of 6-7 centimeters of water (cm H2O) in very low birth weight (VLBW) infants is associated with improved gas exchange without any related changes in vital signs.
Condition: Cancer / Breast Cancer
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to gather information on the safety of TH-302 and its effect on patients with HER2+ breast cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about this specific cancer such as the level of oxygen that is present. This may…
Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of this research study is to find out if the study drug MBG453 in combination with other drugs (decitabine or azacitidine) already commonly used to treat MDS is safe and has beneficial effects in people who have some types of MDS like you (intermediate, high, or very high risk MDS). Subjects will be administered the study treatment as indicated…
Condition: Cancer / Leukemia
Investigator: Mark Frattini, MD, PhD
Status: Closed
Pevonedistat is currently being studied in humans with advanced solid tumors and acute myelogenous leukemia (AML). The current study is designed to evaluate pevonedistat in combination with azacitidine in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and low-blast AML. This study will assess whether taking…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this trial is to determine whether the study drug, CX-839, reduces tumor size in patients with metastatic triple negative breast cancer when it is used in combination with the standard breast cancer treatment. CX-839 blocks the activity of a certain molecule that is overproduced by some cancer cells.
Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to: 1) Test the safety and tolerability of the research study drug, MK-5592 posaconazole (POS), intravenously (IV) and in powder for oral suspension (PFS), 2) Evaluate the pharmacokinetics (how the study drug is absorbed and broken down in the body), of POS IV solution and POS PFS, and 3) Evaluate the taste and reaction to the…
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