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

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

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   

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