High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
OBJECTIVES: I. Describe the toxic effects of ifosfamide, carboplatin, and etoposide (ICE)
with amifostine in patients with metastatic or locally unresectable malignancies who are
undergoing peripheral stem cell transplantation. II. Describe the pharmacokinetic profile
for ifosfamide and its metabolites in patients receiving the maximum tolerated dose of ICE
with amifostine. III. Compare the toxic effects of this study with the toxic effects
observed on protocol 94-078. IV. Compare the pharmacokinetics of ifosfamide on this study
with the pharmacokinetics observed on protocol 94-078.
OUTLINE: Patients undergo peripheral blood stem cell (PBSC) harvest on day -8, followed by
ifosfamide IV, carboplatin IV, and etoposide IV (ICE) by 96 hour continuous infusion on days
-7 to -4. Patients receive amifostine IV twice a day on days -7 to -3. PBSCs are reinfused
on day 0. Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2
hours after infusion of the stem cells and continuing until blood cell counts recover.
Patients are followed monthly for the first 2 months and then for survival.
PROJECTED ACCRUAL: A total of 25 evaluable patients will be accrued for this study within 19
Primary Purpose: Treatment
Paul G.G. Richardson, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|