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A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

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ClinicalTrials.gov Identifier: NCT03593993
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Musella Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Condition or disease Intervention/treatment
Glioma BRAF V600E Pleomorphic Xantho-Astrocytoma Glioblastoma Procedure: Surgical Cohort

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.


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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas
Actual Study Start Date : May 19, 2018
Estimated Primary Completion Date : May 19, 2020
Estimated Study Completion Date : May 19, 2021


Group/Cohort Intervention/treatment
Surgical Cohort
Blood, cerebrospinal fluid, and tumor tissue will be obtained from each participant on this arm.
Procedure: Surgical Cohort
Blood, cerebrospinal fluid, and surgical tissue collected during procedure




Primary Outcome Measures :
  1. Concentration of dabrafenib in brain tumor [ Time Frame: Day 1 ]
    Obtain single time-point concentration of dabrafenib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample

  2. Concentration of trametinib in brain tumor [ Time Frame: Day 1 ]
    Obtain single time-point concentration of trametinib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample


Biospecimen Retention:   Samples With DNA
blood, cerebrospinal fluid, tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary brain tumors who are taking dabrafenib and/or trametinib and are going to have a surgical resection.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593993


Contacts
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Contact: Karisa Schreck 410-955-8837 ksolt1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21228
United States, Massachusetts
Massachusettes General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University Siteman Cancer Center Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashley Fansler, RN    336-713-3539    arcarrol@wakehealth.edu   
Principal Investigator: Roy Strowd, MD         
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: J Wes Heinle       psniclinresearch@pennstatehealth.psu.edu   
Principal Investigator: Michael Glantz, MD         
University of Pennsylvania Abramson Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Minh Dieu    215-615-3673      
Principal Investigator: Stephen Bagley, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Musella Foundation
Investigators
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Principal Investigator: Stuart Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator: Karisa Schreck, MD, PhD Johns Hopkins School of Medicine

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03593993     History of Changes
Other Study ID Numbers: J1801
IRB00158788 ( Other Identifier: JHM IRB )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue