A Multi-Center Phase III Randomized, Controlled Study of Theratope Vaccine for Metastatic Breast Cancer

Date de début de l'étude : 1 janvier 1999

DISEASE CHARACTERISTICS: Histologically or cytologically proven breast cancer Must be enrolled no later than 40 weeks from the start of first line chemotherapy for metastatic disease High dose chemotherapy with bone marrow transplantation or stem cell rescue as part of first line therapy is allowed Either no evidence of disease or nonprogressive disease following first line chemotherapy Patients receiving concurrent hormonal therapy are eligible Patients with bone metastases as the only site of disease are eligible No known brain metastases (patients with stable brain metastases for greater than 6 months may be allowed if not on concurrent corticosteroids) No locoregional disease as the only evidence of metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL Hepatic: SGOT or SGPT no greater than 2.0 times upper limit of normal (ULN) (less than 5 times ULN with liver metastases) Bilirubin no greater than 2.0 times ULN Renal: Creatinine no greater than 2.0 times ULN Cardiovascular: No significant cardiac disease No myocardial infarction within 1 year of study No uncontrolled arrhythmias No uncontrolled hypertension No congestive heart failure Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No prior malignancies within the past 5 years, except: Curatively treated nonmelanoma skin cancer Carcinoma in situ of the cervix No autoimmune disease (e.g., systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, rheumatoid arthritis) No immunodeficiency disease (cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies) Controlled Type II diabetes allowed No clinically significant active infection No known allergy to shellfish No known allergy to soy beans and/or soy products PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferons, tumor necrosis factor, other cytokines or biologic response modifiers, BCG vaccines, or therapeutic monoclonal antibodies Chemotherapy: See Disease Characteristics Must have completed first line chemotherapy for metastatic disease At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroid, cyclosporine, or adrenocorticotropic hormone therapy Radiotherapy: At least 3 weeks since radiation therapy Surgery: At least 4 weeks since prior surgery requiring general anesthetic No splenectomy Other: At least 4 weeks since other investigational drugs Concurrent bisphosphonate therapy allowed provided therapy was initiated more than 3 weeks prior to study