Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
Intervention MeSH terms: Monatide (IMS 3015)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; male breast cancer; invasive lobular breast carcinoma

Summary:

      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill
      more tumor cells.

      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating
      patients with stage III or stage IV breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the breast

               -  Stage III or IV disease

               -  Primary or recurrent disease

               -  Invasive lobular carcinoma allowed

          -  HLA-A1, -A2, -A3, or -A31 positive

          -  Underwent and recovered from prior primary therapy

               -  Patients with no clinical or radiological evidence of disease who had a previous
                  diagnosis of stage III or IV breast cancer must have undergone prior
                  antineoplastic therapy including, but not limited to, surgery, chemotherapy, and
                  radiotherapy within the past 36 months

          -  Must have at least one undissected axillary and/or inguinal lymph node basin

          -  No history of brain metastases

          -  Hormone receptor status

               -  Estrogen receptor-positive or -negative tumor

        PATIENT CHARACTERISTICS:

          -  ECOG performance status of 0 or 1

          -  Body weight > 110 lbs (without clothes)

          -  Male or female

          -  Menopausal status not specified

          -  Absolute neutrophil count > 1000/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin > 9 g/dL

          -  Hemoglobin A1c < 7%

          -  AST and ALT ≤ 2.5 x upper limit of normal (ULN)

          -  Bilirubin ≤ 2.5 x ULN

          -  Alkaline phosphatase ≤ 2.5 x ULN

          -  Creatinine ≤ 1.5 x ULN

          -  HIV negative

          -  Hepatitis C negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known or suspected allergies to any component of the vaccine

          -  No active infection requiring antibiotics

          -  No New York Heart Association class III or IV heart disease

          -  No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune
             disorders with visceral involvement, except the following:

               -  Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without
                  symptoms

               -  Clinical evidence of vitiligo

               -  Other forms of depigmenting illness

               -  Mild arthritis requiring nonsteroidal antiinflammatory drugs

          -  No medical contraindication or potential problem that would preclude study
             participation

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since prior surgery

          -  More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy

          -  More than 4 weeks since prior and no concurrent allergy desensitization injections

          -  More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids

               -  No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)

               -  Prior or concurrent topical corticosteroids allowed

          -  More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa,
             darbepoetin alfa, or pegfilgrastim)

          -  More than 4 weeks since prior and no concurrent other investigational medication

          -  More than 4 weeks since prior and no concurrent other agents with putative
             immunomodulating activity except for non-steroidal anti-inflammatory agents

          -  Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene,
             fulvestrant, letrozole, anastrozole, or exemestane) allowed

          -  No prior vaccination with any synthetic peptides in this protocol

               -  Vaccines for infectious disease (e.g., influenza) allowed, provided they are
                  administered ≥ 2 weeks prior to or ≥ 2 weeks after study vaccine

          -  Short term therapy for acute conditions not related to breast cancer allowed

          -  No concurrent illegal drugs