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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

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE March 4, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE July 19, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
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 ]
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.
Change History Complete list of historical versions of study NCT03861598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • 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 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells
Official Title  ICMJE A Feasibility Study: Evaluating Carvedilol With Chemotherapy in Second Line Glioblastoma Multiforme and Response of Peripheral Glioma Circulating Tumor Cells
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma Multiforme
  • Glioblastoma
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Carvedilol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2019)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sylvia McEwuen, RN 304-293-1683 smcewuen@hsc.wvu.edu
Contact: Rhonda Snyder, RN 304-293-2633 rysnyder@hsc.wvu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03861598
Other Study ID Numbers  ICMJE WVU010318
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE West Virginia Clinical and Translational Science Institute
Investigators  ICMJE
Principal Investigator: Joanna Kolodney, MD West Virginia University
PRS Account West Virginia University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP