A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/17/2019
Start Date:May 19, 2018
End Date:May 19, 2021
Contact:Karisa Schreck
Email:ksolt1@jhmi.edu
Phone:410-955-8837

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A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib 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.
We found this trial at
6
sites
Philadelphia, Pennsylvania 19104
Principal Investigator: Stephen Bagley, MD
Phone: 215-615-3673
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Boston, Massachusetts 02114
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Hershey, Pennsylvania 17033
Principal Investigator: Michael Glantz, MD
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4960 Childrens Place
Saint Louis, Missouri 63110
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Winston-Salem, North Carolina 27157
Principal Investigator: Roy Strowd, MD
Phone: 336-713-3539
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Winston-Salem, NC
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