A Phase I Study of AZD6244 in Pediatric Patients with Recurrent or Refractory Low-Grade Glioma (PBTC-029)

Protocol
12-151
Full Title
PBTC-029B: A Phase 1 and Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Phase
I
Disease Status
Relapsed/Refractory
Purpose

AZD6244 is an investigational drug that inhibits two proteins (MEK1 and MEK2) thought to be involved in the growth of low-grade gliomas. It has been evaluated in adults before, but not in children.

In this Pediatric Brain Tumor Consortium study, researchers want to find the highest dose of AZD6244 that can be given safely in children with low-grade gliomas that continue to grow or have returned despite standard treatment. AZD6244 is a pill that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a low-grade glioma that has continued to grow or has returned despite standard treatment.
  • Patients must be at least age 12 but no older than age 21 at the time of study enrollment.
  • Patients must have recovered from the side effects of prior therapy. At least 3 weeks must have passed since the last cycle of chemotherapy and 12 weeks since the last radiation treatment and entry into the study.
  • Patients may not have had prior treatment with a MEK or BRAF inhibitor.

For more information and to inquire about eligibility for this study, please contact Dr. Ira Dunkel at 212-639-2153.

Disease(s)
Pediatric Brain Tumors: Brain Cancer
Locations
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