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Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells

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ClinicalTrials.gov Identifier: NCT03980249
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
NovoCure Ltd.
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

Brief Summary:
The purpose of this pilot study is to evaluate the addition of carvedilol with standard of care treatment to determine if it will improve progression-free survival in the front line setting in patients with glioblastoma multiforme (GBM). In addition, monitoring of circulating tumor cells (CTCs) by a real-time reverse transcriptase polymerase chain reaction (qRT-PCR) assay to correlate with the clinical findings.

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

Detailed Description:

This is a pilot study to assess efficacy of the addition of a non-selective beta-blocker to standard of care treatment in the front-line setting of glioblastoma multiforme. And to also evaluate the level of peripheral glioma circulating tumor cells via TeleomeScan assay to correlate disease response determined by neuro-imaging.

Peripheral blood samples will be collected at baseline, on day 1 of cycle 1 and then after on day 1 of cycle 4 and at the end of cycle 6 of adjuvant chemotherapy. in order to correlate the biological effects of treatment response. The investigators will evaluate the quantity of peripheral glioma circulating tumor cells and want to apply the information seen in the periphery to the status of the cancer on imaging studies.

Subjects will start oral carvedilol at 6.25 mg orally twice daily and will evaluate the patient and vital status if they tolerate this dose at 1-2 weeks after initiation. If tolerated well, will increase the dose to the maximum anticipation of 12.5 mg orally twice daily. Treatment will proceed for 6 cycles and carvedilol will stop at the end of 6 cycles. Patients will be monitored with neuroimaging prior before chemoradiotherapy, before adjuvant temozolomide and every 2 months on adjuvant temozolomide. Following the completion of 6 cycles of adjuvant therapy, patients will continue to receive neuroimaging on every 3 months' basis until disease progression based upon standard of care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study: Evaluating the Anti-Cancer Effects of Carvedilol With TTFields and Standard of Care in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Carvedilol + Standard Treatment
Subjects will receive carvedilol starting at 6.25 mg orally (PO) twice daily for 1-2 weeks and if tolerated will then be increased to 12.5 mg PO twice daily starting on day 1 of concurrent chemoradiotherapy and continue daily until the end of adjuvant cycle 6 of temozolomide and Tumor Treated Fields.
Drug: Carvedilol
Carvedilol: Start at 6.26 mg PO twice daily for 1-2 weeks and if tolerated, will be increased to 12.5 mg PO twice daily for 6 cycles as tolerated.
Other Name: Coreg




Primary Outcome Measures :
  1. Survival curve of overall survival [ Time Frame: From start of carvedilol treatment until the date of first documented progression or death which ever comes first (approximately 6-15 months) ]
    Kaplan-Meier curves for overall survival in order to see if the addition of carvedilol to standard of care appears promising from a clinical standpoint

  2. Survival curve of progression free survival [ Time Frame: From start of carvedilol treatment until the date of first documented progression or death which ever comes first (approximately 6-15 months) ]
    Kaplan-Meier curves for progression free survival in order to see if the addition of carvedilol to standard of care appears promising from a clinical standpoint


Secondary Outcome Measures :
  1. Quantify Circulating Tumor Cells (CTCs) [ Time Frame: Baseline (prior to any treatment), Cycle 1 Day 1, Cycle 4 day 1, End of cycle 6 of Chemotherapy (each cycle is 28 days) ]
    Quantify CTCs via qRT-PCR assay and to assess how the trend of CTCs correspond to disease status as measured by RANO criteria on neuro-imaging.



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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:

  • Subjects must have histologically or cytologically confirmed WHO Grade IV Glioblastoma
  • Subjects must have not received previous chemotherapy or radiation therapy for GBM
  • Subjects must have systolic blood pressure greater than or equal to 90 and heart rate >59
  • Subjects who are on beta-blockers for other etiologies may enroll on study and switch therapy to carvedilol if deemed medical appropriate per treating physician

Exclusion Criteria:

  • Subjects receiving any other investigational agents
  • Subjects who have severe and uncontrolled asthma, COPD
  • Systolic blood pressure <90 mmHg or HR <60 bpm without antihypertensive medications at baseline
  • Subjects with uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Allergy to beta blockers

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): NCT03980249


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 Not yet recruiting
Morgantown, West Virginia, United States, 26506
Contact: Sylvia McEwuen, RN    304-293-1683    smcewuen@hsc.wvu.edu   
Contact: Rhonda Snyder, RN    304-293-2633    rysnyder@hsc.wvu.edu   
Principal Investigator: Joanna Kolodney, MD         
Sub-Investigator: Michael Kolodney, MD         
Sub-Investigator: Gary Marano, MD         
Sub-Investigator: Rashi Mehta, MD         
Sub-Investigator: Geraldine Jacobson, MD         
Sub-Investigator: Paul Renz, DO         
Sub-Investigator: Rachel Hagen, BS         
Sponsors and Collaborators
West Virginia University
NovoCure Ltd.
West Virginia Clinical and Translational Science Institute
Investigators
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Principal Investigator: Joanna Kolodney, MD West Virginia University
  Study Documents (Full-Text)

Documents provided by West Virginia University:
Informed Consent Form  [PDF] April 1, 2019


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Responsible Party: West Virginia University
ClinicalTrials.gov Identifier: NCT03980249     History of Changes
Other Study ID Numbers: WVU020318
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Glioblastoma
Neoplastic Cells, Circulating
Astrocytoma
Glioma
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