Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed By Surgery

Hepatocellular Carcinoma Clinical Trial

Official title: A Pilot Study of Beta-Blockers in Patients With Advanced Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Carcinoma, Hepatocellular
• Carcinoma, Ovarian Epithelial
• Hepatocellular Carcinoma
• Male Breast Cancer
• Melanoma
• Neoplasms
• 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

• NCT number: NCT02013492
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Status: Completed
• Phase: Early Phase 1
• Start date: January 21, 2014
• Completion date: June 12, 2015