NCT02013492

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: William Carson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	propranolol hydrochloride	Given PO
OTHER	Correlative Studies	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.

Timeline

• Start date: 2014-01-21
• Primary completion: 2015-06-12
• Completion: 2015-06-12
• First posted: 2013-12-17
• Last updated: 2022-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study