Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03980249|
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioblastoma Multiforme||Drug: Carvedilol||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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
- 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
- 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.
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
|Contact: Sylvia McEwuen, RNemail@example.com|
|Contact: Rhonda Snyder, RNfirstname.lastname@example.org|
|United States, West Virginia|
|WVU Cancer Institute - Mary Babb Randolph Cancer Center|
|Morgantown, West Virginia, United States, 26506|
|Contact: Sylvia McEwuen, RN 304-293-1683 email@example.com|
|Contact: Rhonda Snyder, RN 304-293-2633 firstname.lastname@example.org|
|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|
|Principal Investigator:||Joanna Kolodney, MD||West Virginia University|