Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed By Surgery
|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: NCT02013492|
Recruitment Status : Recruiting
First Posted : December 17, 2013
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Male Breast Cancer Recurrent Melanoma Stage IV Breast Cancer Stage IV Melanoma Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Hepatocellular Carcinoma||Drug: propranolol hydrochloride Other: Correlative Studies||Early Phase 1|
I. To determine the feasibility and tolerability of beta-adrenergic blockade in patients with metastatic or locally advanced cancer.
II. To determine the effects of beta-adrenergic blockade on the tumor microenvironment and host immune system via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells from the study patients.
I. Evaluate the effects of beta-adrenergic blockade on progression-free survival and overall survival.
Patients receive propranolol hydrochloride orally (PO) twice daily (BID) for 4 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Beta-Blockers in Patients With Advanced Cancer|
|Actual Study Start Date :||January 21, 2014|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Treatment (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO BID for 4 months in the absence of disease progression or unacceptable toxicity. Propranolol will be administered on an out-patient basis. Blood for correlative studies (30 ml - green top tube) will be drawn at baseline and at each clinic visit. Tumor tissue for analysis will be obtained via core needle biopsy (or other appropriate modality) pre-study and at approximately the two month time point.
Drug: propranolol hydrochloride
Other Name: Inderal
Other: Correlative Studies
Correlative studies will be conducted using the following materials:
- Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) V. 4.0 [ Time Frame: Up to 4 months ]A dose-limiting toxicity (DLT) will be considered as any grade 3 or higher hematologic or non- hematologic toxicity that is probably or definitely related to treatment.
- Change in vascular endothelial growth factor (VEGF) [ Time Frame: Baseline to 4 months ]
- Effect of beta-adrenergic blockade on the tumor microenvironment [ Time Frame: Up to 4 months ]Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.
- Effect of beta-adrenergic blockade on the host immune system [ Time Frame: Up to 4 months ]Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.
- Progression-free survival [ Time Frame: Up to 1 year ]
- Overall survival [ Time Frame: Up to 1 year ]
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): NCT02013492
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSCCCCClinicaltrials@osumc.edu|
|Contact: Lauren Kuleszafirstname.lastname@example.org|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: William E. Carson, MD 614-293-6306 email@example.com|
|Principal Investigator: William E. Carson, MD|
|Principal Investigator:||William Carson, MD||Ohio State University Comprehensive Cancer Center|