Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer
Condition: Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male
Intervention: vorinostat; laboratory biomarker analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating
      patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as
      suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic
      acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed stage IV adenocarcinoma
             of the breast; tumor blocks and/or slides from original diagnosis or metastatic
             work-up must be available for correlative studies

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             20 mm with conventional techniques or as > 10 mm with spiral CT scan

          -  Prior adjuvant therapy, and up to 2 lines of prior chemotherapy (including trastuzumab
             containing regimens in Her-2 positive patients) for metastatic disease are allowed;
             prior radiation therapy is allowed, prior hormonal therapy is allowed

          -  Life expectancy of greater than 6 months

          -  Performance status: ECOG 0- 2

          -  Absolute neutrophil count >= 1,000/μl

          -  Platelets >= 100,000/μl

          -  Serum creatinine =< 1.6 mg/dl or calculated measured clearance >= 60 cc/min

          -  Total bilirubin =< 2 mg/dL

          -  AST and ALT =< 3 times institutional upper normal level

          -  Eligibility of patients receiving any medications or substances known to affect or
             with the potential to affect the activity or pharmacokinetics of SAHA will be
             determined following review by the Principal Investigator

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Patients should not have taken valproic acid for at least two weeks prior to study
             entry

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases are excluded from this clinical trial unless the
             metastases are controlled after therapy and have not been treated with steroids within
             the past two months

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SAHA; these compounds include sodium butyrate, trichostatin A (TSA),
             trapoxin (TPX), MS-27-275 and depsipeptide

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because SAHA is a HDAC inhibitor agent
             with an unknown potential for teratogenesis; because there is an unknown but potential
             risk for adverse events in nursing infants secondary to treatment of the mother with
             SAHA, breastfeeding should be discontinued if the mother is treated with SAHA

          -  HIV-positive patients receiving combination antiretroviral therapy are ineligible
             because of the potential for pharmacokinetic interactions with SAHA