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ACTIVE NOT RECRUITING
NCT04201457
PHASE1/PHASE2

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

Sponsor: Pediatric Brain Tumor Consortium

View on ClinicalTrials.gov

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.

Official title: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-associated Recurrent or Progressive Gliomas in Children and Young Adults

Key Details

Gender

All

Age Range

1 Year - 30 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2020-01-17

Completion Date

2026-03-31

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

Dabrafenib

Dabrafenib capsule; Dabrafenib Dispersible Tablet

DRUG

Trametinib

Tablet; Powder for Oral Solution

DRUG

Hydroxychloroquine

Tablet

Locations (15)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

National Cancer Institute Pediatric Oncology Branch

Bethesda, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cincinnati Children Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

St. Jude Children Research Hospital

Memphis, Tennessee, United States

Texas Children's Cancer Center

Houston, Texas, United States