Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed By Surgery
Male Breast Cancer
Stage IV Breast Cancer
Stage IV Melanoma
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Drug: propranolol hydrochloride
Other: Correlative Studies
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Beta-Blockers in Patients With Advanced Cancer|
- Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) V. 4.0 [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Effect of beta-adrenergic blockade on the tumor microenvironment [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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: InderalOther: Correlative Studies
Correlative studies will be conducted using the following materials:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013492
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|Contact: William Carson, MD||614-293-6306||William.Carson@osumc.edu|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: William E. Carson, MD 614-293-6306 firstname.lastname@example.org|
|Principal Investigator: William E. Carson, MD|
|Principal Investigator:||William Carson, MD||Ohio State University Comprehensive Cancer Center|