A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients
I. Determine whether high dose chemotherapy in addition to growth factors increases the
yield of filgrastim mobilized progenitor cells.
II. Determine the kinetics of hematopoietic reconstitution following myeloablative therapy
and mobilized blood stem cell transplantation.
III. Determine whether the use of high dose chemotherapy in addition to growth factors for
mobilization of stem cells reduces risk of relapse as measured by time to progression in
responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell
or bone marrow transplants.
IV. Determine the morbidity and cost differences of the use of high dose chemotherapy plus
growth factors compared to growth factors alone for mobilization of peripheral blood
progenitors and treatment of breast cancer with high dose chemotherapy.
OUTLINE: Patients will be randomized into 2 groups. Group 1 patients undergo CVP
chemotherapy treatment by vein (IV) on days 1-3, with cyclophosphamide (CTX), etoposide, and
cisplatin. Filgrastim SC (subcutaneously) is given on day 4 every 12 hours until completion
of apheresis. Group 2 patients only receive filgrastim SC given on day 1 every 12 hours
until completion of apheresis. Stem cells are removed beginning on day 4 for a maximum of 6
days. Upon recovery of hematopoiesis patients then receive high IV doses of CBT chemotherapy
with CTX, carmustine, and thiotepa for 3 days, followed 4 days later by autologous stem cell
reinfusion. Beginning on day of reinfusion, filgrastim is given bid until WBC reaches a safe
level. Patients are followed for 90 days posttransplant, and then followed indefinitely for
antitumor response and time to progression.
PROJECTED ACCRUAL: This study will include about 218 patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone
90 Days Post Transplant
James Gajewski, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|