A Phase II Study of Dabrafenib plus Trametinib after Radiation Therapy for Newly Diagnosed High-Grade Glioma

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Full Title

ACNS1723: A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND #145355) (CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of giving the drugs dabrafenib and trametinib after radiation therapy in children, adolescents, and young adults with newly diagnosed high-grade glioma that has been surgically removed and contains a particular mutation in a gene called BRAF.

Dabrafenib works by blocking the mutated BRAF protein, which lets cancer cells grow without stopping. Trametinib blocks another protein, called MEK, which also fuels cancer cell growth. These two drugs are already used together to treat melanoma and lung cancer that contains mutated BRAF. Their use in this study is considered investigational. Both medications are 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 be age 3 to 21 years.
  • Patients must have operable high-grade glioma that contains a BRAF V600 mutation.
  • Patients may not have received prior treatment for their glioma other than surgery.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Stephen Gilheeney at 212-639-3973.

Protocol

20-063

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators