Trial Information

A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation

OBJECTIVES: I. Evaluate the role of amifostine in reducing hematologic toxicity and
improving mobilization of peripheral progenitor stem cells in patients with recurrent or
refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing platinum based
salvage chemotherapy. II. Evaluate the role of amifostine in preventing renal toxicity in
these patients.

OUTLINE: This is an randomized, open label study. Patients are randomized to receive salvage
chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without
amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2
doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks
for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses
of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration.
Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients
receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization.
PSC transplant continues daily for 4-10 days.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study.