Trial Information

High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer

OBJECTIVES: I. Evaluate the complete and partial remission rates and event free and overall
survival of patients with metastatic hormone refractory prostate cancer treated with high
dose chemotherapy plus peripheral stem cell transplantation followed by consolidation
chemotherapy. II. Evaluate the toxic effects associated with this treatment in these
patients. III. Evaluate the quality of life, and need for analgesics, in these patients.

OUTLINE: Patients are stratified by stage of disease and extent of metastatic disease.
Patients receive daily filgrastim (G-CSF) subcutaneously for 4 days until peripheral blood
stem cells are collected. Patients then receive carmustine IV over 2 hours on day -2 and
melphalan IV over 20 minutes on day -1. Stem cell infusion will be on day 0. At 3, 6, 9, and
12 months after transplant, patients receive vinorelbine IV over 10 minutes and cisplatin IV
over 24 hours. Quality of life and pain are assessed before the transplantation, just before
discharge after transplantation, prior to each consolidation course, and then at 3, 6, and
12 months after the final course of chemotherapy. Patients are followed at least every 3
months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 2 years.