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Naltrexone in Treating Women With Metastatic Breast Cancer That Did Not Respond to Hormone Therapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379197
  Purpose

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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer CT Scans Cancer
Drug Information available for: Naltrexone Fluorodeoxyglucose F18 Naltrexone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity and adverse events as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Median time to event (first time when maximum SUV is higher than that at baseline) within 1 year of study entry [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2006
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic breast cancer
  • Disease must have progressed despite prior systemic hormonal therapy
  • Measurable disease
  • No brain metastases unless stable for 1 month or more after radiation therapy
  • Hormone receptor-positive disease

PATIENT CHARACTERISTICS:

  • Female
  • Pre- or post-menopausal
  • Karnofsky performance status 80-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST and ALT < 2 times ULN (≤ 5 times ULN if liver has tumor involvement)
  • Creatinine < 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for 3 months after completion of study treatment
  • No pain uncontrolled with the use of non-narcotic drugs (acetaminophen or nonsteroidal medications)
  • No history of sensitivity to naltrexone
  • No acute hepatitis or liver failure
  • No positive urine screen for opiods

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • No hormonal therapy within the past 2 weeks
  • No chemotherapy, immunotherapy, or biologic therapy within the past 3 weeks
  • No short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, or tramadol) within the past 10 days
  • No concurrent immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or other indications
  • No concurrent surgery or other procedures that will require narcotic analgesics
  • No concurrent narcotic analgesics for pain
  • No concurrent short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, or tramadol)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379197

Locations
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        
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Tufia Haddad, MD Masonic Cancer Center, University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
Skin Diseases
Naltrexone
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009