NCT03593993

A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma
• BRAF V600E
• Pleomorphic Xantho-Astrocytoma
• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Surgical Cohort	Blood, cerebrospinal fluid, and surgical tissue collected during procedure

Timeline

• Start date: 2018-05-19
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2018-07-20
• Last updated: 2023-10-06

Locations

5 sites across 1 country: United States