Dabrafenib and Trametinib for Low-Grade Gliomas

Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

Recruiting Phase 2 Interventional Study
BRAF V600 Mutation Low-grade Glioma Low Grade Glioma of Brain Recurrent Low Grade Glioma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 Months – 25
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for

This trial is looking for patients with low-grade gliomas that have a specific gene mutation. Participants will take the drugs dabrafenib and trametinib and may either stop them completely or reduce the dose slowly over six months after already being on them for 12-24 months.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have low-grade glioma with a BRAF V600 mutation.
  • I have measurable tumor.
  • I am between 12 months and 25 years old.
  • I have a performance score of 50 or higher.
  • I have not received radiation treatment if I am in Cohort 1.
  • I have recovered from chemotherapy for at least 3 weeks.
  • I have a normal blood cell count.
  • I can understand and sign an informed consent.

You may not be able to join if

  • I have had prior radiation if I am in Cohort 1.
  • I have received chemotherapy less than 3 weeks before enrollment.
  • I have taken biologic or small molecule agents within the last 7 days.
  • I have a severe seizure disorder that is not well controlled.
  • I have significant kidney or liver problems.
  • I have a left ventricular ejection fraction below normal.
  • I cannot agree to use adequate contraception during the trial.
  • I am unable to understand the consent documents.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 tria…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing * Participants must have measurable tumor. \* For participants with measurable disease, this will be def…
Contacts

Jacqueline Ayyoub

415-502-1600

PNOC037@ucsf.edu

CONTACT

Kelly Hitchner

415-502-1600

PNOC037@ucsf.edu

CONTACT