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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00379197 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using 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 blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that did not respond to previous hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: fludeoxyglucose F 18 Drug: naltrexone hydrochloride Procedure: computed tomography Procedure: positron emission tomography |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Principal Investigator: | Tufia Haddad, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Tufia Haddad ) |
Study ID Numbers: | CDR0000500134, UMN-2006LS016, UMN-0604M85308 |
Study First Received: | September 19, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00379197 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Naltrexone Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Physiological Effects of Drugs |
Narcotic Antagonists Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |