Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells
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| ClinicalTrials.gov Identifier: NCT03861598 |
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Recruitment Status :
Recruiting
First Posted : March 4, 2019
Last Update Posted : August 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma Multiforme Glioblastoma | Drug: Carvedilol | Early Phase 1 |
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 : | Interventional |
| Estimated Enrollment : | 6 participants |
| Allocation: | N/A |
| 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 : | July 1, 2021 |
| Estimated Study Completion Date : | July 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| Contact: Sylvia McEwuen, RN | 304-293-1683 | smcewuen@hsc.wvu.edu | |
| Contact: Rhonda Snyder, RN | 304-293-2633 | rysnyder@hsc.wvu.edu |
| 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 | |
| Principal Investigator: | Joanna Kolodney, MD | West Virginia University |
| Responsible Party: | West Virginia University |
| ClinicalTrials.gov Identifier: | NCT03861598 |
| Other Study ID Numbers: |
WVU010318 |
| First Posted: | March 4, 2019 Key Record Dates |
| Last Update Posted: | August 4, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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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 |