Clinical Trial: 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

This study has been completed.

Sponsored by: Jonsson Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
Waldenstrom's Macroglobulinemia
recurrent adult Hodgkin's disease
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Drug: amifostine
 Drug: cisplatin
 Drug: cytarabine
 Drug: dexamethasone
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Hodgkin's Disease;   Immune System and Disorders;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase II Randomized Study of Amifostine with Platinum Based Salvage Chemotherapy in Patients with Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Autologous Progenitor Stem Cell Transplantation

Further Study Details: 

Study start: November 1997

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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


Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Christos E. Emmanouilides,  Study Chair,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065926; UCLA-HSPC-970708701; NCI-V97-1362; ALZA-UCLA-HSPC-970708701
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003143
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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