Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00379197|
Recruitment Status : Terminated (slow accrual)
First Posted : September 21, 2006
Results First Posted : May 19, 2017
Last Update Posted : December 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: naltrexone Procedure: PET scan||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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: REVIA
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.
Other Name: Positron-emission tomography scan
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|