Actively Recruiting
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
Led by University of California, San Francisco · Updated on 2026-04-30
96
Participants Needed
5
Research Sites
333 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
R
Rising Tide Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.
CONDITIONS
Official Title
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed low-grade glioma (WHO Grade I or II) with BRAF V600 mutation
- Participants must have measurable tumor lesions or be followed for survival and progression
- Cohort 1: No prior therapy except surgery; may be on dabrafenib and trametinib frontline therapy up to 21 months without confirmed best response
- Cohort 2: History of recurrent or progressive disease after prior therapy; may be retreated with dabrafenib and trametinib beyond 6 months after previous treatment
- Last dose of chemotherapy at least 3 weeks prior (6 weeks for nitrosoureas) and recovered from side effects
- At least 7 days since last biologic or small molecule therapy (except dabrafenib and trametinib)
- No prior radiation for Cohort 1; specific radiation timing requirements for Cohort 2
- Age between 12 months and under 25 years
- Performance score of 50 or higher (Karnofsky or Lansky scales)
- Adequate blood counts and organ function
- Seizure disorder allowed if well controlled
- Normal heart function and QT interval
- Agreement to use contraception if of childbearing potential
- Ability to understand and sign consent
- Enrollment in Pediatric Neuro-Oncology Consortium follow-up if available
- Submission of pathology and genetic reports confirming BRAF V600E mutation
You will not qualify if you...
- Tumors with additional activating mutations such as IDH1/IDH2, Histone H3, or NF-1 loss
- Receiving other investigational agents
- History of allergic reactions to similar drugs
- Use of medications affected by dabrafenib's enzyme induction without caution
- Uncontrolled illnesses or active infections
- Pregnant or breastfeeding women
- HIV positive with unstable therapy or severe immunocompromise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
John Hopkins Medical Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
St. Louis Children's Hospital Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
5
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
J
Jacqueline Ayyoub
CONTACT
K
Kelly Hitchner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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