Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Conditions

• Anaplastic Astrocytoma
• Anaplastic Astrocytoma, Not Otherwise Specified
• Anaplastic Ganglioglioma
• Anaplastic Pleomorphic Xanthoastrocytoma
• Glioblastoma
• Malignant Glioma
• WHO Grade 3 Glioma
• WHO Grade 4 Glioma

Eligibility Criteria

Sex

ALL

Age

3 Years - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Dabrafenib Mesylate — DRUG
  Given PO
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Radiation Therapy — RADIATION
  Undergo RT
• Trametinib Dimethyl Sulfoxide — DRUG
  Given PO

Study Details

This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.

Key Dates

Start date

Feb 20, 2020

Status verified

Jan 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

58 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (radiation therapy, dabrafenib, trametinib)
  Patients undergo standardized local RT 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline, on day 1 of cycles 1, 3, 5, 7, 11, 14, 17, 20, and 23 while on treatment, then at time of relapse, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, and annually for years 4-5. Patients may also undergo lumbar puncture for CSF testing during treatment. Patients also undergo collection of blood on study.

Primary Outcome Measure

Event-free survival (EFS) for stratum 1 [ Time Frame: From the date of diagnosis until disease progression date, secondary malignant neoplasm occurrence date, death date of any cause, or last follow-up, assessed up to 5 years ]

Locations (130)

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