A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

NCT03593993 | Terminated

• 2 other identifiers: J1801IRB00158788
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 5

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.

Conditions

Glioma; BRAF V600E; Pleomorphic Xantho-Astrocytoma; Glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Surgical Cohort

Blood, cerebrospinal fluid, and tumor tissue will be obtained from each participant on this arm.

Procedure: Surgical Cohort

Interventions

Surgical Cohort PROCEDURE

Blood, cerebrospinal fluid, and surgical tissue collected during procedure

Surgical Cohort

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Musella Foundation: collaborator

Study Sites (5)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21228, United States

Location

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, cerebrospinal fluid, tumor tissue

MeSH Terms

Conditions

Glioma; Astrocytoma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Stuart Grossman, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

• Karisa Schreck, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 20, 2018
• Study Start: May 19, 2018
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)