A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-19

Study Completion Date

2023-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a surgical biospecimen collection study. The purpose of this study is to understand how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn off the RAF signaling pathway. This is important because these drugs are currently FDA approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03919071

Anaplastic Astrocytoma Anaplastic Astrocytoma, Not Otherwise Specified Anaplastic Ganglioglioma +5 more

ACTIVE_NOT_RECRUITING PHASE2

Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

NCT07110246

BRAF V600 Mutation Low-grade Glioma Low Grade Glioma of Brain +1 more

RECRUITING PHASE2

Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

NCT01721603

BRAFV600E Melanoma Patients

TERMINATED PHASE2

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

NCT02684058

Diffuse Astrocytoma Anaplastic Astrocytoma Astrocytoma +19 more

COMPLETED PHASE2

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma

NCT03224767

BRAF V600E Mutation Present Papillary Craniopharyngioma

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary goal of this study is to establish concentrations of dabrafenib and trametinib in enhancing brain tissue and cerebrospinal fluid from people with BRAF-V600E mutant recurrent gliomas who undergo tumor resection. The exploratory goals are to measure the amount of ERK signaling pathway activity, to identify mechanisms of resistance to these drugs, and evaluate feasibility of measuring tumor DNA in cerebrospinal fluid.

People (adults or children) with brain tumors who are already taking dabrafenib and / or trametinib and are in need of a surgical resection are potentially eligible. On the day of surgery, blood, cerebrospinal fluid, and tumor tissue will be collected for research purposes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma BRAF V600E Pleomorphic Xantho-Astrocytoma Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical Cohort

Blood, cerebrospinal fluid, and tumor tissue will be obtained from each participant on this arm.

Surgical Cohort

Intervention Type PROCEDURE

Blood, cerebrospinal fluid, and surgical tissue collected during procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical Cohort

Blood, cerebrospinal fluid, and surgical tissue collected during procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
* Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
* Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician. Note: Pediatric patients may be taking any dose of dabrafenib and / or trametinib as prescribed by their treating physician for at least 7 days prior to surgery.
* Subjects must be undergoing surgery for clinical purposes.
* Written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation will be obtained according to institutional guidelines.

Exclusion Criteria

* Subjects who are receiving any other investigational agents or chemotherapeutic agents.
* Subjects for whom collection of blood, spinal fluid, or tissue samples is unsafe or clinically inadvisable.

Minimum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No