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

NCT ID: NCT03861598

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2021-06-17

Brief 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.

Detailed Description

This will be a feasibility study to assess the use of a new PCR assay with response to standard chemotherapy treatment in the second line setting in glioblastoma multiforme (GBM). The change in direction with the combination of carvedilol with standard of chemotherapy based upon brain MRI results will be assessed and associating that with also the change in the quantity of tumor cells with a new invented assay device. Six subjects will be enrolled in the study who have recurrent GBM and will be receiving second line treatment.

The subjects will receive standard therapy per the discretion of the treating oncologist. Carvedilol will start at 6.25 mg orally twice daily for 1-2 weeks to confirm tolerance. The subjects will then receive carvedilol at 12.5 mg orally twice daily as the maximum dose and take it continuously for 4 cycles of therapy. At the completion of 4 cycles, patients will stop taking carvedilol. If the patients were on previous anti-hypertensive medications, they will be instructed to restart those medications if stopped on this trial for carvedilol.

Peripheral blood samples will be collected at baseline before initiation of treatment, on first day of every cycle for four cycles and after the last cycle is completed to obtain peripheral glioma circulating tumor levels. Subjects will be re-evaluated for response every 2 cycles of therapy with brain MRI with and without contrast.

Conditions

Glioblastoma Multiforme; Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Carvedilol orally with standard chemotherapy starting at 6.25 mg and increasing to 12.5 mg if tolerated after 1-2 weeks for a total of 4 cycles of treatment.

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

Carvedilol orally starting at 6.25 mg and increasing to 12.5 mg if tolerated after 1-2 weeks for a total of 4 cycles of treatment.

Interventions

Carvedilol

Carvedilol orally starting at 6.25 mg and increasing to 12.5 mg if tolerated after 1-2 weeks for a total of 4 cycles of treatment.

Intervention Type: DRUG

Other Intervention Names

Coreg; Coreg CR

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia Clinical and Translational Science Institute

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Kolodney, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

WVU Cancer Institute - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

WVU010318

Identifier Type: -

Identifier Source: org_study_id