Clinical Trial Finder

A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 6 Weeks and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03593993

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Stuart Grossman, MDKarisa Schreck, MD, PhD
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsJohns Hopkins School of Medicine

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Glioma, BRAF V600E, Pleomorphic Xantho-Astrocytoma, Glioblastoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21228

Site Contact

410-955-8837

Massachusettes General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusettes General Hospital

Boston, Massachusetts, 02114

Site Contact

410-955-8837

Saint Louis, Missouri

Status

Not yet recruiting

Address

Washington University Siteman Cancer Center

Saint Louis, Missouri, 63110

Site Contact

410-955-8837

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Site Contact

Ashley Fansler, RN

arcarrol@wakehealth.edu

336-713-3539

Penn State Hershey Medical Center, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Site Contact

410-955-8837

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy