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NCT03919071 · ClinicalTrials.gov registry record · Phase 2

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

A Phase 2 study of Glioblastoma and Malignant Glioma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
58
Enrollment target
20
Study locations

NCT03919071 is a Phase 2 study of Glioblastoma and Malignant Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT03919071, a Phase 2 study of Glioblastoma and Malignant Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
58 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Lumbar Puncture
  • PROCEDURE Magnetic Resonance Imaging
  • RADIATION Radiation Therapy
  • DRUG Dabrafenib Mesylate

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • Loma Linda University Medical Center - Loma Linda
  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • Kaiser Permanente-Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Lucile Packard Children's Hospital Stanford University - Palo Alto
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • UCSF Medical Center-Mission Bay - San Francisco
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix

Connecticut

  • Connecticut Children's Medical Center - Hartford
  • Yale University - New Haven

Alabama

  • Children's Hospital of Alabama - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Delaware

  • Alfred I duPont Hospital for Children - Wilmington

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2020-02-20
Est. Completion 2027-09-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03919071

The ClinicalTrials.gov registry entry for NCT03919071 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (47% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03919071 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03919071 about?

NCT03919071 is a clinical study titled "Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma". This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of ...

What is the current status of trial NCT03919071?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-02-20. Estimated completion is 2027-09-30.

What conditions does trial NCT03919071 study?

This clinical trial studies the following conditions: Glioblastoma, Malignant Glioma, Anaplastic Astrocytoma, WHO Grade 3 Glioma, WHO Grade 4 Glioma.

What interventions are being tested in trial NCT03919071?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Radiation Therapy (RADIATION), Dabrafenib Mesylate (DRUG).

Who is sponsoring clinical trial NCT03919071?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03919071 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.