Phase 1 Study of MK-1775 Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas
Study of New Drug with Radiation Therapy in Children with Diffuse Intrinsic Pontine Gliomas (DIPG) Brain Stem Cancer
Sponsor: Children's Oncology Group
Enrolling: Male and Female Patients
Study Length: 6 Weeks
IRB Number: AAAM3003
U.S. Govt. ID: NCT01922076
Contact: Rebecca Zylber, NP: 212-305-7212 /
Additional Study Information: 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 selective Wee1 kinase inhibitor that works by inhibiting cancer cell growth. In this study, MK-1775 will be administered in combination with standard radiation therapy regimen. The purpose of this study is to evaluate the toxicities and clinical activity of MK-1775 in children with newly diagnosed with DIPG. Radiation therapy will be given at the current standard dose once daily Monday through Friday for a total of 30 doses over 6 weeks. K-1775 will also be given based on the assigned dose level once daily Monday through Friday after that days radiation therapy, for a total of 30 doses over 6 weeks. Disease assessment will be completed before beginning treatment, before starting a new cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study. During every cycle, blood samples will be collected to determine how much MK-1775 is in the blood (pharmacokinetics). The blood tests will help us to better learn how to use this drug for children who may receive it in the future.
This study is closed
Luca Szalontay, MD
Do You Qualify?
Is the patient between 36 months and 21 years of age? Yes No
Has the patient been newly diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG)? Yes No
Has the patient receive any prior cancer therpay such as chemotherapy, radiation, immunotherapy or bone marrow transplant? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Rebecca Zylber, NP