This pilot trial studies propranolol hydrochloride in treating patients with locally recurrent or metastatic solid tumors that cannot be removed by surgery. Propranolol hydrochloride may slow the growth of tumor cells by blocking the use of hormones by the tumor cells.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. Evaluate the effects of beta-adrenergic blockade on progression-free survival and overall survival. OUTLINE: 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Given PO
Correlative studies will be conducted using the following materials: * Plasma derived from peripheral blood. * Peripheral blood mononuclear cells (PBMC) derived from patient blood * Tumor tissue obtained at the time of core needle biopsy at the 2 month time point. * Paraffin-embedded tumor tissue obtained pre-therapy to make the diagnosis of metastatic disease.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) V. 4.0
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.
Time frame: Up to 4 months
Change in vascular endothelial growth factor (VEGF)
Time frame: Baseline to 4 months
Effect of beta-adrenergic blockade on the tumor microenvironment
Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.
Time frame: Up to 4 months
Effect of beta-adrenergic blockade on the host immune system
Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.
Time frame: Up to 4 months
Progression-free survival
Time frame: Up to 1 year
Overall survival
Time frame: Up to 1 year
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