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

• Status: Withdrawn
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Collaborators: NovoCure Ltd.; West Virginia Clinical and Translational Science Institute
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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