Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells

NCT03980249 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: WVU020318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the addition of carvedilol with standard of care treatment to determine if it will improve progression-free survival in the front line setting in patients with glioblastoma multiforme (GBM). In addition, monitoring of circulating tumor cells (CTCs) by a real-time reverse transcriptase polymerase chain reaction (qRT-PCR) assay to correlate with the clinical findings.

Conditions

Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

• Survival curve of overall survival

  Kaplan-Meier curves for overall survival in order to see if the addition of carvedilol to standard of care appears promising from a clinical standpoint

  From start of carvedilol treatment until the date of first documented progression or death which ever comes first (approximately 6-15 months)

• Survival curve of progression free survival

  Kaplan-Meier curves for progression free survival in order to see if the addition of carvedilol to standard of care appears promising from a clinical standpoint

  From start of carvedilol treatment until the date of first documented progression or death which ever comes first (approximately 6-15 months)

Secondary Outcomes (1)

• Quantify Circulating Tumor Cells (CTCs)

  Baseline (prior to any treatment), Cycle 1 Day 1, Cycle 4 day 1, End of cycle 6 of Chemotherapy (each cycle is 28 days)

Study Arms (1)

Carvedilol + Standard Treatment

EXPERIMENTAL

Subjects will receive carvedilol starting at 6.25 mg orally (PO) twice daily for 1-2 weeks and if tolerated will then be increased to 12.5 mg PO twice daily starting on day 1 of concurrent chemoradiotherapy and continue daily until the end of adjuvant cycle 6 of temozolomide and Tumor Treated Fields.

Drug: Carvedilol

Interventions

Carvedilol DRUG

Carvedilol: Start at 6.26 mg PO twice daily for 1-2 weeks and if tolerated, will be increased to 12.5 mg PO twice daily for 6 cycles as tolerated.

Also known as: Coreg

Carvedilol + Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed WHO Grade IV Glioblastoma
• Subjects must have not received previous chemotherapy or radiation therapy for GBM
• Subjects must have systolic blood pressure greater than or equal to 90 and heart rate \>59
• Subjects who are on beta-blockers for other etiologies may enroll on study and switch therapy to carvedilol if deemed medical appropriate per treating physician

You may not qualify if:

• Subjects receiving any other investigational agents
• Subjects who have severe and uncontrolled asthma, COPD
• Systolic blood pressure \<90 mmHg or HR \<60 bpm without antihypertensive medications at baseline
• Subjects with uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Allergy to beta blockers

Sponsors & Collaborators

• West Virginia University: lead
• NovoCure Ltd.: collaborator
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

WVU Cancer Institute - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Joanna Kolodney, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: June 10, 2019
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)