Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer
OBJECTIVES: I. Determine the safety and toxicity profile, specifically cardiac toxicity, of
trastuzumab (Herceptin) following high dose chemotherapy and autologous peripheral blood
stem cell transplantation in women with metastatic breast cancer. II. Determine the time to
disease progression and disease free survival in these patients when treated with this
regimen. III. Determine the impact of trastuzumab (Herceptin) on minimal residual disease
after autologous peripheral blood stem cell transplantation as evidenced by serial
immunocytochemical analysis of bone marrow. IV. Determine the relationship between
posttransplant reconstitution of antibody dependent cellular toxicity and the efficacy of
trastuzumab (Herceptin) in these patients.
OUTLINE: This is a multicenter study. Patients undergo stem cell mobilization with growth
factors alone (filgrastim (G-CSF) and/or sargramostim (GM-CSF)) or chemotherapy followed by
growth factors (depending on center). Peripheral blood stem cells (PBSC) are then collected
by leukapheresis. Patients then receive high dose chemotherapy consisting of
cyclophosphamide IV over 1 hour and cisplatin IV over 72 hours on days -6 to -4 and
carmustine IV on day -3 or cyclophosphamide IV, thiotepa IV, and carboplatin IV over 96
hours on days -7 to -4 (depending on center). PBSC are reinfused on day 0. Patients then
receive trastuzumab IV over 30-90 minutes weekly for 1 year or until disease progression
beginning 5-8 weeks after PBSC reinfusion.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
David Avigan, MD
Study Chair
Beth Israel Deaconess Medical Center
United States: Federal Government
CDR0000068138
NCT00006123
July 2000
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |