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Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

NCT00379197•Masonic Cancer Center, University of Minnesota

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+2 more criteria

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

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

May 1, 2013

Completion Date

May 1, 2013

Last Updated

December 28, 2017

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

naltrexone

DRUG

PET scan

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer