Study on Dabrafenib and Trametinib After Radiation Therapy for Newly Diagnosed High-Grade Glioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03919071

Provider View

This clinical trial is testing whether the combination of two drugs, dabrafenib and trametinib, can improve treatment outcomes for children and young adults with high-grade glioma, a type of brain tumor, after they have received radiation therapy.

Patient Parameters

Program Overview

The purpose of this study is to see if using the drugs dabrafenib and trametinib after radiation therapy can help control high-grade glioma in children and young adults who have a specific genetic change called the BRAF V600 mutation. Radiation therapy uses high-energy rays to kill cancer cells, and these drugs may help stop the growth of tumor cells by blocking certain enzymes they need to grow. The study aims to find out if this combination works better than past treatments for newly diagnosed patients with this type of brain tumor.

Description

The main goal of this study is to see how long patients with newly diagnosed high-grade glioma, who have the BRAF V600 mutation, can live without their disease getting worse when treated with radiation therapy followed by dabrafenib and trametinib. The study will compare these results to those from past treatments.

Secondary goals include understanding overall survival rates and how well patients with specific types of glioma respond to this treatment. The study will also look at any side effects from the combination of dabrafenib and trametinib after radiation therapy.

Patients will first receive radiation therapy five days a week for 6-7 weeks. About a month after finishing radiation, they will start taking dabrafenib twice a day and trametinib once a day in 28-day cycles, for up to 24 cycles, as long as the disease does not progress and side effects are manageable. Regular MRI scans will be done to monitor the tumor's response to treatment. Blood samples and possibly spinal fluid samples will be collected for further study.

After completing the treatment, patients will have follow-up visits to monitor their health and any signs of the disease returning.

Eligibility Criteria

Inclusion Criteria

  • Must be 3 to 25 years old.
  • Must have a newly diagnosed high-grade glioma with the BRAF V600 mutation.
  • Must not have any signs of the disease spreading to other parts of the body.
  • Must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
  • Must have adequate blood cell counts and organ function based on specific medical tests.
  • Must not have received any prior treatment for their glioma, except for surgery or corticosteroids.
  • Must be able to start the study treatment within 31 days after surgery.
  • Must agree to provide tumor samples for research purposes.
  • Must have signed informed consent from themselves or their guardians.

Exclusion Criteria

  • Cannot have tumors in the brainstem or spinal cord.
  • Cannot have metastatic disease, meaning the cancer has spread to other parts of the body.
  • Cannot have received any previous treatments like chemotherapy or radiation for their glioma.
  • Cannot have a history of allergic reactions to similar drugs.
  • Cannot have uncontrolled medical conditions or infections.
  • Cannot have a history of heart disease or other serious health issues that could increase risks during the study.
  • Cannot be pregnant or breastfeeding, and must agree to use effective birth control during and after the study if of childbearing potential.

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