Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells

• Status: Terminated
• Trial end date: 2021-06-17
• Target enrollment: 0
• Participant gender: All

Summary

Subjects will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Carvedilol will start at 6.25 mg orally twice a day and be increased to 12.5 mg orally twice daily after 1 to 2 weeks if tolerated. Peripheral glioma circulating tumor cells (CTC) and brain MRI with and without contrast will be obtained at baseline, 2 cycles, and 4 cycles to determine the efficacy and direction of change of the CTC using a new assay tool. Preliminary assessment of the tolerability of Carvedilol with standard chemotherapy will also be evaluated.

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

Details

• Lead Sponsor: West Virginia University
• Collaborator: West Virginia Clinical and Translational Science Institute
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Grade IV Glioblastoma, receiving chemotherapy with or without TTfields.

• Progressive or recurrent disease requiring second line treatment

• evidence of progression of disease by brain MRI and are planned to receive chemotherapy

Exclusion Criteria:

• Current use of another beta blocker that cannot be switched to carvedilol at the onset of the trial.

• Systolic blood pressure <90 mmHg and/or heart rate <60 bpm without hypertensive medications

• Allergy to beta blockers

• Severe or uncontrolled asthma or COPD (chronic obstructive pulmonary disease)