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 - Article
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.
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
recurrent adult Hodgkin's disease
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
| Drug: amifostine |
|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
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.
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
PROTOCOL ENTRY CRITERIA:
- 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
- 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
- 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
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States
Christos E. Emmanouilides, Study Chair, Jonsson Comprehensive Cancer Center
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
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)