Study on Dabrafenib, Trametinib, and Hydroxychloroquine for Patients with Recurrent Brain Tumors with BRAF Mutation

Sponsor: Pediatric Brain Tumor Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04201457

Provider View

This clinical trial is testing a combination of three drugs—dabrafenib, trametinib, and hydroxychloroquine—to see if they can help treat children with brain tumors that have specific genetic changes and have not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of adding hydroxychloroquine to dabrafenib and trametinib in children with brain tumors that have specific genetic changes, known as BRAF mutations. These tumors have either not responded to previous treatments or have returned. Hydroxychloroquine may help stop tumor growth by killing the cells or preventing them from dividing. Dabrafenib and trametinib work by blocking certain enzymes needed for tumor growth. The study aims to see if this combination can better control brain tumors compared to usual treatments.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective doses of the drug combination for children and young adults with brain tumors that have specific BRAF mutations or are associated with neurofibromatosis type 1. The goal is to find the best way to use dabrafenib and trametinib by overcoming resistance that has been seen in similar cases. Patients will take the drugs orally, and treatment may continue for up to two years if the tumors do not progress and side effects are manageable.

In Phase II, patients will continue to receive the drug combination at the doses determined in Phase I. The study will monitor the effectiveness of the treatment in shrinking tumors and preventing their growth. Patients will need to provide MRI scans for review to confirm eligibility and track the tumor's response to the treatment.

The study will also look at how the drugs affect the tumor environment and resistance mechanisms, which could help improve future treatments for similar brain tumors.

Eligibility Criteria

Inclusion Criteria

  • Have a specific type of brain tumor with a BRAF mutation that has come back or not responded to previous treatments.
  • Be between 1 and 18 years old.
  • Weigh at least 9 kg.
  • Have received previous treatment with RAF or MEK inhibitors.
  • Have measurable disease that can be tracked with scans.
  • Be in good overall health with stable neurological symptoms.
  • Meet specific blood count and organ function requirements.
  • Agree to use effective birth control during the study and for a period after treatment.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Women who are breastfeeding.
  • Have significant unrelated health issues that could interfere with the study.
  • Have a history of severe eye problems.
  • Have active digestive issues that affect drug absorption.
  • Cannot stop taking certain medications or herbal supplements before the study.
  • Are currently receiving other cancer treatments.
  • Have allergies to any of the study drugs.
  • Are unable to attend follow-up visits or comply with study requirements.

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