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ADVL1514: A Phase 1 Study of ABI-009 (nab-rapamycin) in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan
Study of Experimental Drug in Pediatric Patients with Solid Tumors, including CNS Tumors
Sponsor:Children's Oncology Group
Enrolling:Male and Female Patients
Age Range:Between 1 and 21 years old
IRB Number:AAAR5342
U.S. Government ID:NCT02975882
Contact: Alice Lee, MD: 212-305-5808 / al2041@cumc.columbia.edu
Additional Study Information:

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 States (US) Food and Drug Administration (FDA) for treating children and young adults with tumors, including CNS tumors. Both temozolomide and irinotecan are drugs that are FDA-approved for other indications. The purpose of this study is to learn what kind of side effects ABI-009 given as a single agent and incombination with temozolomide and irinotecan can cause and to find the highest dose of ABI-009 that can be given safely. During Cycle 1, ABI-009 will be given as an intravenous infusion over 30 minutes on Days 1 and 8 of Cycle 1 (a cycle of therapy is 21 days). During Cycle 2 and subsequent cycles, ABI-009 will be given as an intravenous infusion over 30 minutes on Days 1 and 8 of each cycle in combination with temozolomide and irinotecan (given by mouth once daily on Days 1-5 of each cycle). Cefixime or an available equivalent antibiotic will be used to treat diarrhea during Cycle 2 and subsequent cycles. Disease assessment will be completed before beginning treatment, at the end of Cycles 1 and 2 and then every other cycle. Blood samples will be collected to determine how much ABI-009 (nab-Rapamycin) and Irinotecan is in the blood during the study (pharmacokinetics).

Do You Qualify?
Is your child between 12 months and 21 years of age?YesNo
Has your child been diagnosed with solid tumors, including central nervous system (CNS) tumors or lymphoma?YesNo
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Who Can I Contact?
For more information, please contact:
Alice Lee, MD
Email: al2041@cumc.columbia.edu
Phone: 212-305-5808