Trial record 1 of 12 for:    naltrexone AND cancer
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Naltrexone in Treating Women With Metastatic Breast Cancer That Did Not Respond to Hormone Therapy

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00379197
First received: September 19, 2006
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: naltrexone hydrochloride
Procedure: Positron-emission tomography (PET) / computed tomography (CT)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Disease Response [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Disease assessment based on change in specific uptake value (SUV) numbers between baseline fludeoxyglucose F 18 (FDG) positron emission tomography (PET)-CT scan, and FDG-PET-CT scan at weeks 4 and 8


Secondary Outcome Measures:
  • Median time to event [ Time Frame: From Baseline to 1 Year ] [ Designated as safety issue: No ]
    first time when maximum SUV is higher than that at baseline) within 1 year of study entry


Enrollment: 13
Study Start Date: July 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).
Drug: naltrexone hydrochloride
Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.
Other Name: REVIA®
Procedure: Positron-emission tomography (PET) / computed tomography (CT)
Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.
Other Name: PET-CT

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379197

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Douglas Yee, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00379197     History of Changes
Other Study ID Numbers: 2006LS016, UMN-0604M85308
Study First Received: September 19, 2006
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
stage IV breast cancer, estrogen receptor positive
recurrent breast cancer
hormone-refractory, metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Naltrexone
Breast Diseases
Skin Diseases
Hormones
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 27, 2014