Naltrexone in Treating Women With Metastatic Breast Cancer That Did Not Respond to Hormone Therapy
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.
Drug: naltrexone hydrochloride
Procedure: Positron-emission tomography (PET) / computed tomography (CT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer|
- Disease Response [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]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
- Median time to event [ Time Frame: From Baseline to 1 Year ] [ Designated as safety issue: No ]first time when maximum SUV is higher than that at baseline) within 1 year of study entry
|Study Start Date:||July 2006|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).
Drug: naltrexone hydrochloride
Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.
Other Name: REVIA®Procedure: Positron-emission tomography (PET) / computed tomography (CT)
Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.
Other Name: PET-CT
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379197
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Douglas Yee, MD||Masonic Cancer Center, University of Minnesota|