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A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration

NCT04201457 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-02-03

No results posted yet for this study

Summary

This phase I/II trial is designed to study the side effects, best dose and efficacy of adding hydroxychloroquine to dabrafenib and/or trametinib in children with low grade or high grade brain tumors previously treated with similar drugs that did not respond completely (progressive) or tumors that came back while receiving a similar agent (recurrent). Patients must also have specific genetic mutations including BRAF V600 mutations or BRAF fusion/duplication, with or without neurofibromatosis type 1. Neurofibromatosis type 1 is an inherited genetic condition that causes tumors to grow on nerve tissue. Hydroxychloroquine, works in different ways to stop the growth of tumor cells by killing the cells or stopping them from dividing. Trametinib and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine with trametinib and/or dabrafenib may lower the chance of brain tumors growing or spreading compared to usual treatments.

Conditions

  • Low Grade Glioma (LGG) of Brain With BRAF Aberration
  • High Grade Glioma (HGG) of the Brain With BRAF Aberration
  • Low Grade Glioma of Brain With Neurofibromatosis Type 1

Interventions

DRUG

Dabrafenib

Dabrafenib capsule; Dabrafenib Dispersible Tablet

DRUG

Trametinib

Tablet; Powder for Oral Solution

DRUG

Hydroxychloroquine

Tablet

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • American Lebanese Syrian Associated Charities

    collaborator OTHER

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Lindsey Hoffman, DO · Phoenix Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201457 on ClinicalTrials.gov