Vaccine Therapy in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether THERATOPE vaccine therapy is more effective than standard vaccine therapy in treating metastatic breast cancer.
PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of THERATOPE vaccine therapy with that of standard vaccine therapy in treating women who have metastatic breast cancer.
Biological: Detox-B adjuvant
Biological: THERATOPE STn-KLH vaccine
Biological: keyhole limpet hemocyanin
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Multi-Center Phase III Randomized, Controlled Study of Theratope Vaccine for Metastatic Breast Cancer|
|Study Start Date:||January 1999|
|Study Completion Date:||December 2008|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare time to disease progression in patients receiving THERATOPE vaccine to that of women receiving control vaccine. II. Compare survival in patients receiving THERATOPE vaccine to that of patients receiving control vaccine. III. Document the product safety profile in these patients. IV. Measure the anti-STn, anti-OSM, and anti-KLH antibody titers. V. Evaluate the impact of THERATOPE STn-KLH vaccine on health-related quality of life in these patients.
OUTLINE: The study design is a prospective, double-blinded, randomized study. Patients who have completed first-line chemotherapy for metastatic breast cancer and have either nonprogressive disease or no evidence of disease following completion of first-line chemotherapy (includes bone marrow transplants and stem cell rescue) will be randomized to either the THERATOPE vaccine or the control vaccine. Patients are stratified at entry according to disease status (i.e., either no evidence of disease or nonprogressive disease) and whether or not they are receiving hormonal therapy for metastatic disease while on study. Arm I: Patients receive intravenous cyclophosphamide on day -3, followed by 4 subcutaneous vaccinations with THERATOPE STn-KLH vaccine combined with Detox-B Stable Emulsion at 0, 2, 5, and 9 weeks. Arm II: Patients receive the control treatment of intravenous cyclophosphamide on day -3, followed by 4 subcutaneous vaccinations with keyhole limpet hemocyanin (KLH) vaccine combined with Detox-B Stable Emulsion at 0, 2, 5, and 9 weeks. Patients with stable or responding disease may receive the THERATOPE STn-KLH vaccine or control without Detox-B Stable Emulsion at weeks 13, 17, 21, and 25. Patients without unacceptable toxic effects or disease progression may continue on maintenance therapy at 3 month intervals.
PROJECTED ACCRUAL: Over 120 sites in North America, Europe, and Australia/New Zealand will be participating in the study. A total of 950 women (475 per treatment arm) will be enrolled into the study.