Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer
- Determine the efficacy of naltrexone in women with hormone-refractory, metastatic
breast cancer as measured by serial fludeoxyglucose F 18 positron emission
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease assessment based on change in specific uptake value (SUV) numbers between baseline fludeoxyglucose F 18 (FDG) positron emission tomography (PET)-CT scan, and FDG-PET-CT scan at weeks 4 and 8
Week 4 and Week 8
Douglas Yee, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|