Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 ]A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.
- Median Time to Event [ Time Frame: From Baseline to 1 Year ]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 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.
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.
Other Name: REVIAProcedure: 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.
Other Name: Positron-emission tomography scan
- 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|