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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003143
• Other study ID #: CDR0000065926
• Secondary ID: UCLA-HSPC-970708
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: October 3, 2012
• Start date: November 1997

Study information

• Verified date: October 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Amifostine

• DHAP

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States,