Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Stem Cell Transplantation

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Completed	Over 18	Pharmaceutical / Industry	UCLA-HSPC-970708701 ALZA-UCLA-HSPC-970708701, NCI-V97-1362, NCT00003143

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.

Entry Criteria

Disease Characteristics:

Histologically proven recurrent or refractory non-Hodgkin's lymphoma or
Hodgkin's disease requiring salvage chemotherapy
  Prior treatment with at least 3 courses of first line chemotherapy
  

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior high dose chemotherapy with stem cell transplant
 At least 3 courses of first line chemotherapy

Endocrine therapy:
 Not specified
 
Radiotherapy:
 Not specified

Surgery:
 Not specified

Patient Characteristics:

Age:
 Over 18

Performance Status:
 ECOG 0-2

Life Expectancy:
 Greater than 3 months

Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 50,000/mm3

Hepatic:
 Not specified
 
Renal:
 Creatinine no greater than 1.5 mg/dL
 Creatinine clearance at least 40 mL/min

Cardiovascular:
 No symptomatic congestive heart failure (class III or more as defined by     
  American Heart Association)

Electrolytes:
 Potassium at least 3.4 meq/L
 Magnesium at least 1.4 meq/L

Other:
 Not pregnant or nursing

Expected Enrollment

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

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. 

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Christos Emmanouilides, MD, Protocol chair		Ph: 310-206-0716; 888-798-0719 Email: cemmanou@mednet.ucla.edu

Registry Information
Official Title		A Randomized Study of Ethyol (Amifostine) with Platinum Based Salvage Chemotherapy in Patients with Lymphoma Undergoing Autologous Stem Cell Transplantation
Trial Start Date		1997-11-16
Registered in ClinicalTrials.gov		NCT00003143
Date Submitted to PDQ		1997-11-20
Information Last Verified		2007-05-14

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