Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
OBJECTIVES: 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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
