← Back to Search

Dabrafenib + Trametinib for High-Grade Glioma

Eastern Maine Medical Center, Bangor, ME
Targeting 7 different conditionsRadiation Therapy +5 morePhase 2RecruitingLed by Rishi R LullaResearch Sponsored by National Cancer Institute (NCI)

Study Summary

This trial studies how well a 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.

Eligible Conditions
  • Anaplastic Ganglioglioma
  • Anaplastic Astrocytoma
  • Gliomas
  • Pleomorphic Xanthoastrocytoma
  • Glioblastoma
  • Malignant Glioma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (EFS) for stratum 1
Secondary outcome measures
Event-free survival (EFS) for stratum 2 and stratum 3
Incidence of adverse events
Overall survival (OS) for stratum 1, stratum 2, and stratum 3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, dabrafenib, trametinib)Experimental Treatment6 Interventions
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
Completed Phase 1
Radiation Therapy
Completed Phase 3
Lumbar Puncture
Completed Phase 3
Magnetic Resonance Imaging
Completed Phase 3
Dabrafenib Mesylate
Completed Phase 2
Trametinib Dimethyl Sulfoxide
Completed Phase 2

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,492 Previous Clinical Trials
41,267,526 Total Patients Enrolled
Rishi R LullaPrincipal InvestigatorChildren's Oncology Group

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03919071 — Phase 2
Anaplastic Astrocytoma Research Study Groups: Treatment (radiation therapy, dabrafenib, trametinib)
Anaplastic Astrocytoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT03919071 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03919071 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being treated with this medication in this clinical trial?

"Yes, the information available on clinicaltrials.gov suggests that this trial is still recruiting patients. The first posting was on October 2nd, 2019 and the most recent update was on November 8th, 2020. There are currently 100 sites enrolling 58 participants each."

Answered by AI

Is this clinical trial open to patients who are under the age of 75?

"Children as young as one year old and adults up to 21 years of age are eligible for this trial, which is one of 682 clinical trials specifically for people under 18."

Answered by AI

Are there any specific requirements for participants in this clinical trial?

"This clinical trial is recruiting 58 participants, between the ages of 12 Months and 21 who have glioblastoma. It is required that patients also meet the following criteria: -PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patient is suspected of having localized newly-diagnosed HGG, excluding metastatic disease., Results for H3 K27M by immunohistochemistry (IHC) or sequencing-PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patients must be >= 12 months and =< 21 years of age at"

Answered by AI

Are there any treatments like Radiation Therapy that have been approved by the FDA?

"Radiation therapy is considered to be a safe treatment option, but its efficacy has not been proven. Therefore, it receives a score of 2."

Answered by AI

Does this form of treatment have a precedent?

"The University of Chicago Medical Center first began studying Radiation Therapy in 2012 and, since then, 252 completed studies have been published. There are currently 99 ongoing trials worldwide with a significant portion taking place in Savannah, Georgia."

Answered by AI

Is this clinical trial taking place in more than a few hospitals in America?

"There are 100 sites conducting this study, for example Memorial Health University Medical Center in Savannah, University of Chicago Comprehensive Cancer Center in Chicago, and East Tennesseee Cancer Center in Chicago, and East Tennessee Childrens Hospital in Knoxville."

Answered by AI

Are people still being enrolled in this experiment as of right now?

"The clinical trial is enrolling 58 patients at 100 sites."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Johns Hopkins University/Sidney Kimmel Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

~29 spots leftby Sep 2027