Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: allogeneic GM-CSF-secreting breast cancer vaccine; trastuzumab; cyclophosphamide
Intervention description: Given intradermally; Given IV; Given IV
Intervention MeSH terms: Cyclophosphamide; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; male breast cancer

Summary:

      RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective
      immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and
      trastuzumab, may increase the number of immune cells and make the immune response stronger.
      It is not yet known whether giving cyclophosphamide together with vaccine therapy is more
      effective with or without trastuzumab in treating patients with metastatic breast cancer.

      PURPOSE: This randomized phase II trial is studying the side effects of giving
      cyclophosphamide together with vaccine therapy and to see how well it works compared with
      giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients
      with metastatic breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast

               -  Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC

               -  Stage IV disease

          -  Must not be eligible for therapy of known curative potential for metastatic breast
             cancer

          -  Measurable or evaluable disease

          -  Stable CNS disease allowed provided that it's adequately treated and not under active
             treatment

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Menopausal status not specified

          -  ECOG performance status 0-1

          -  ANC > 1,000/mm^3

          -  Platelets > 100,000/mm^3

          -  Serum bilirubin < 2.0 mg/dL (unless due to Gilbert syndrome)

          -  AST and ALT < 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 5 times ULN

          -  Serum creatinine < 2.0 mg/dL

          -  Ejection fraction normal by MUGA OR ≥ 50% by echocardiogram

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  Asthma or chronic obstructive pulmonary disease that does not require daily systemic
             corticosteroids allowed

          -  No prior or concurrent autoimmune disease requiring management with systemic
             immunosuppression, including any of the following:

               -  Inflammatory bowel disease

               -  Systemic vasculitis

               -  Scleroderma

               -  Psoriasis

               -  Multiple sclerosis

               -  Hemolytic anemia or immune-mediated thrombocytopenia

               -  Rheumatoid arthritis

               -  Systemic lupus erythematosus

               -  Sjogren syndrome

               -  Sarcoidosis

               -  Other rheumatologic disease

          -  No other malignancies within the past 5 years, except carcinoma in situ of the cervix,
             superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related
             endometrial cancer that has been adequately treated

          -  No active major medical or psychosocial problems that could be complicated by study
             participation

          -  No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs
             resulting in dyspnea at rest

          -  No uncontrolled medical problems

          -  No evidence of active acute or chronic infection

          -  No known severe hypersensitivity to trastuzumab, except mild to moderate infusion
             reactions that are easily managed and do not recur

          -  No allergy to corn

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 28 days since prior and no other concurrent chemotherapy, radiation therapy,
             or biologic therapy (except trastuzumab)

               -  Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed

          -  More than 28 days since prior and no other concurrent participation in an
             investigational new drug trial

          -  More than 28 days since prior and no other concurrent systemic oral steroids

               -  Topical, ocular, and nasal steroids allowed

          -  No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine