Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: naltrexone; PET scan
Intervention description: 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.; 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer, estrogen receptor positive; recurrent breast cancer; hormone-refractory, metastatic breast cancer

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.
    

Eligibility 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