Spots Global Cancer Trial Database for A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas
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Trial Identification
Brief Title: A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas
Official Title: A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas
Study ID: NCT03593993
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 6 Weeks
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusettes General Hospital, Boston, Massachusetts, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Stuart Grossman, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: PRINCIPAL_INVESTIGATOR
Name: Karisa Schreck, MD, PhD
Affiliation: Johns Hopkins School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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