Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Tracking Information
First Submitted Date ICMJE	September 19, 2006
First Posted Date ICMJE	September 21, 2006
Results First Submitted Date	April 22, 2015
Results First Posted Date	May 19, 2017
Last Update Posted Date	December 28, 2017
Study Start Date ICMJE	July 2006
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 13, 2017)	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.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00379197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 13, 2017)	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.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
Official Title ICMJE	Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer
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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Drug: naltrexone 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
Study Arms	Experimental: Naltrexone; 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.; Interventions: Drug: naltrexone; Procedure: PET scan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: July 25, 2013)	13
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	May 2013
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Metastatic, hormone-receptor positive breast cancer; Disease that has progressed despite previous systemic hormonal therapy. Hormone therapy must be terminated at least 2 weeks prior to study enrollment.; Prior chemotherapy, immunotherapy, or biological therapy is allowed if at least 3 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.; Measurable disease as defined by solid tumor response (RECIST) criteria or non-measurable bone disease that is Positron-emission tomography (PET) avid; Karnofsky performance status >70%; Female, age 18 years or older; Adequate organ function within 14 days of study enrollment including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10^9/L, platelets >75 x 10^9/L, and hemoglobin > 8 g/dL Hepatic: bilirubin ≤ 2 times the upper limit of normal (× ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN. (AST and ALT ≤ 5 × ULN is acceptable if liver has tumor involvement) Renal: creatinine ≤ 2 times the upper limit of normal; Women of childbearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.; Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion criteria: Brain metastases unless stable for 1 month or more following radiation therapy.; Pregnant or lactating women. PET-CT is not approved during pregnancy. A negative urine or serum pregnancy test is required for all females of child bearing potential within 7 days prior to study entry. Pregnancy testing is not required for post-menopausal or surgically sterilized women.; Use of any short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, tramadol) within 10 days prior to study enrollment; Pain uncontrolled with the use of non-narcotic drugs (acetaminophen or non-steroidal medications); History of sensitivity to naltrexone; Acute hepatitis or liver failure; Immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or other indications
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00379197
Other Study ID Numbers ICMJE	2006LS016; UMN-0604M85308 ( Other Identifier: IRB, University of Minnesota )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Masonic Cancer Center, University of Minnesota
Study Sponsor ICMJE	Masonic Cancer Center, University of Minnesota
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Douglas Yee, MD Masonic Cancer Center, University of Minnesota
PRS Account	Masonic Cancer Center, University of Minnesota
Verification Date	December 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP