Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379197
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-09-19
Brief Title:
Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Phase II Study of Naltrexone for the Treatment of Hormone-Refractory Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-0604M85308 | OTHER | IRB University of Minnesota | None |