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

NCT03861598 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: WVU010318
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Identify the correlation between our new RT-qPCR assay for circulating tumor cells and the change in responses in patients on treatment to MRI results.

  Identify the correlation between our new RT-qPCR assay for circulating tumor cells and the change in responses in patients on treatment to MRI results. We will use 1 to indicate progression of disease seen on brain MRI, 2 to indicate stability or no change in imaging, and 3 to indicate response to treatment. The correlation will be assessed by Spearman's Rank Correlation coefficient. We will have six patients on this study which will give us 12 changed measurements.

  Baseline, end of cycle 2, end of cycle 4, approximately 6 months depending on treatment plan

Secondary Outcomes (2)

• Evaluate response with the addition of carvedilol to standard chemotherapy in the second line treatment in glioblastoma multiforme

  Baseline, end of cycle 2, end of cycle 4, approximately 6 months depending on treatment plan

• Evaluate incidents of adverse events during the time subjects are taking carvedilol with chemotherapy

  From Baseline to 30 days after stopping carvedilol.

Study Arms (1)

Cohort 1

EXPERIMENTAL

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.

Drug: Carvedilol

Interventions

Carvedilol 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.

Also known as: Coreg, Coreg CR

Cohort 1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• West Virginia University: lead
• 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: February 11, 2019
• First Posted: March 4, 2019
• Study Start: July 19, 2019
• Primary Completion: August 21, 2020
• Study Completion: June 17, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)