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A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065926

NCT ID:

NCT00003143

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Waldenström macroglobulinemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781