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

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ClinicalTrials.gov Identifier: NCT03861598
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Glioblastoma Drug: Carvedilol Early Phase 1

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.


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Study Type : Interventional
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study: Evaluating Carvedilol With Chemotherapy in Second Line Glioblastoma Multiforme and Response of Peripheral Glioma Circulating Tumor Cells
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Coreg
  • Coreg CR




Primary Outcome Measures :
  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. [ Time Frame: Baseline, end of cycle 2, end of cycle 4, approximately 6 months depending on treatment plan ]
    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.


Secondary Outcome Measures :
  1. Evaluate response with the addition of carvedilol to standard chemotherapy in the second line treatment in glioblastoma multiforme [ Time Frame: Baseline, end of cycle 2, end of cycle 4, approximately 6 months depending on treatment plan ]
    Evaluate response with the addition of carvedilol to standard chemotherapy in the second line treatment in glioblastoma multiforme. Evaluate the correlation between changes in measurements derived from this new assay with changes in a numerical scale based upon brain 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. We are evaluating the changes of responses in patients on treatment to MRI results and correlate those with our new RT-qPCR assay for circulating tumor cells.

  2. Evaluate incidents of adverse events during the time subjects are taking carvedilol with chemotherapy [ Time Frame: From Baseline to 30 days after stopping carvedilol. ]
    Evaluate adverse events during the time subjects are taking carvedilol with chemotherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861598


Contacts
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Contact: Sylvia McEwuen, RN 304-293-1683 smcewuen@hsc.wvu.edu
Contact: Rhonda Snyder, RN 304-293-2633 rysnyder@hsc.wvu.edu

Locations
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United States, West Virginia
WVU Cancer Institute - Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Sylvia McEwuen, RN    304-293-1683    smcewuen@hsc.wvu.edu   
Sponsors and Collaborators
West Virginia University
West Virginia Clinical and Translational Science Institute
Investigators
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Principal Investigator: Joanna Kolodney, MD West Virginia University

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Responsible Party: West Virginia University
ClinicalTrials.gov Identifier: NCT03861598     History of Changes
Other Study ID Numbers: WVU010318
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Glioblastoma
Neoplastic Cells, Circulating
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists