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ACTIVE NOT RECRUITING Phase 1

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

NCT04201457 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Trametinib
  • DRUG Dabrafenib
  • DRUG Hydroxychloroquine

Study Locations (15)

California

  • Children's Hospital Los Angeles — Los Angeles
  • Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto

Ohio

  • Cincinnati Children Hospital Medical Center — Cincinnati
  • Nationwide Children's Hospital — Columbus

Arizona

  • Phoenix Children's Hospital — Phoenix

Colorado

  • Children's Hospital Colorado — Aurora

District of Columbia

  • Children's National Medical Center — Washington D.C.

Florida

  • University of Florida — Gainesville

Georgia

  • Children's Healthcare of Atlanta — Atlanta

Illinois

  • Lurie Children's Hospital-Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2020-01-17
Est. Completion 2026-03-31
Phase Phase 1

Sponsor

Pediatric Brain Tumor Consortium

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04201457

The ClinicalTrials.gov registry entry for NCT04201457 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pediatric Brain Tumor Consortium, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Low Grade Glioma (LGG) of Brain With BRAF Aberration appearing as the primary indexed condition, and to 3 interventions — of which Trametinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04201457 reports 15 study locations spanning 13 distinct geographic areas — top geographies include California, Ohio, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04201457 about?

NCT04201457 is a clinical study titled "A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration". 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 ca...

What is the current status of trial NCT04201457?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2020-01-17. Estimated completion is 2026-03-31.

What conditions does trial NCT04201457 study?

This clinical trial studies the following 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04201457?

The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Hydroxychloroquine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04201457?

This trial is sponsored by Pediatric Brain Tumor Consortium, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04201457 being conducted?

This trial has 15 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial