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Title:
A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas
Protocol Number:
J1801
Phase:
Pilot
Physician:
Stuart Grossman
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
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. 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.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.
Eligibility:
Patient's age is greater than or equal to newborn. Histopathological diagnosis of a primary brain tumor. BRAF V600 mutation identified by PCR or next generation sequencing (attach confirmatory test). Patient is taking dabrafenib at least 50mg twice daily if adult, or any dose if pediatric AND / OR patient is taking trametinib at least 1mg daily if adult, or any dose if pediatric. Patient is undergoing a planned tumor resection for clinical purposes. Patient or guardian is able to understand and sign written informed consent.
Treatment:
People of all ages with high grade primary brain tumors that have grown back after standard treatment with two specific drugs (dabrafenib and trametinib) and will be having surgery to remove the tumor may join. This includes anaplastic astrocytomas, glioblastomas, and anaplastic pleomorphic xanthoastrocytomas, among others. On the day of surgery, blood, cerebrospinal fluid, and tumor tissue will be collected for research purposes.
Population:
Both
Last Update
12/09/2019 05:03 AM