NCT00379197

Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by impairing blood flow to the tumor. PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that is no longer responsive to previous hormone therapy.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of naltrexone in women with hormone-refractory, metastatic breast cancer as measured by serial fludeoxyglucose F 18 positron emission tomography-CT scans. Secondary * Determine the safety of naltrexone in these patients. * Determine the median time to event (first time when maximum specific uptake values is higher than that at baseline) within 1 year of study entry. OUTLINE: This is an open-label study. Patients receive oral naltrexone once daily for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 weeks, patients may continue naltrexone off study at the discretion of the physician. Patients undergo fludeoxyglucose F 18 positron emission tomography-CT scans at baseline, week 4, week 8, and periodically thereafter. After completion of study treatment, patients are followed for up to 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	naltrexone	Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.
PROCEDURE	PET scan	Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Timeline

• Start date: 2006-07-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2006-09-21
• Last updated: 2017-12-28
• Results posted: 2017-05-19

Locations

1 site across 1 country: United States