A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas
A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas
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.
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.
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.