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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03593993
Other study ID # J1801
Secondary ID IRB00158788
Status Terminated
Phase
First received
Last updated
Start date May 19, 2018
Est. completion date July 7, 2023

Study information

Verified date October 2023
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Intervention

Procedure:
Surgical Cohort
Blood, cerebrospinal fluid, and surgical tissue collected during procedure

Locations

Country Name City State
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States Massachusettes General Hospital Boston Massachusetts
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Musella Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of dabrafenib in brain tumor Obtain single time-point concentration of dabrafenib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample Day 1
Primary Concentration of trametinib in brain tumor Obtain single time-point concentration of trametinib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample Day 1
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