Lymphoma Clinical Trial
Official title:
A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy
with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's
lymphoma or Hodgkin's disease who are 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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