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Dabrafenib + Trametinib After Radiation for Brain Cancer

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: 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 <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Chicago, and East <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a> Childrens Hospital in Knoxville.

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

The clinical trial is enrolling 58 patients at 100 sites.

Phase 2

Recruiting

Led By Rishi R Lulla

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed high-grade glioma with BRAF^V600-mutation

Results for H3 K27M by immunohistochemistry (IHC) or sequencing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

Who is the study for?

This trial is for children and young adults aged between 1 to 21 years with newly-diagnosed high-grade glioma that has a specific genetic change (BRAF V600 mutation). They must not have had any previous tumor-directed therapy other than surgery or corticosteroids, should be in good health otherwise, and able to follow the study procedures. Pregnant or breastfeeding females are ineligible, as well as those with certain medical conditions like uncontrolled heart disease.Check my eligibility

What is being tested?

The trial tests how well dabrafenib combined with trametinib works after radiation therapy in patients with BRAF V600-mutant high-grade glioma. Dabrafenib targets the BRAF enzyme while trametinib targets MEK; both enzymes are involved in tumor cell growth. The goal is to see if this combination improves outcomes compared to past treatments.See study design

What are the potential side effects?

Potential side effects include allergic reactions similar to those from compounds related to dabrafenib and trametinib, issues affecting drug absorption due to gastrointestinal diseases, liver problems from hepatitis B/C infections, increased risk of cardiac events such as heart attacks or angina, vision problems like retinal vein occlusion or central serous retinopathy.

Eligibility Criteria

Inclusion Criteria

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

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My brain tumor is newly diagnosed, high-grade, and has a BRAF V600 mutation.

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My tumor tested positive for H3 K27M mutation.

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I can take care of myself but may not be able to do active work.

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My spinal fluid test was negative for cancer cells.

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I am suspected to have a new high-grade glioma without spread.

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My liver enzyme (SGPT/ALT) levels are within the required range for the study.

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I have a high-grade brain tumor (grade III or IV).

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My diagnosis of a high-grade brain tumor has been confirmed by tissue examination.

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I am 25 years old or younger.

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My treatment will start within 31 days after my final cancer surgery.

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I am between 3 and 25 years old.

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My kidney function, based on my age and gender, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Radiation Therapy

2017

Completed Phase 3

~7250

Lumbar Puncture

2016

Completed Phase 3

~510

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,463 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 Tennessee Childrens Hospital in Knoxville."

Answered by AI