Phase II Study of High-Dose Cytarabine, Cisplatin, and Dexamethasone Followed By Cyclophosphamide, Etoposide, Total Body Irradiation, and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the toxicity and activity of cyclophosphamide, etoposide, total
body irradiation, and autologous bone marrow transplantation in patients with relapsed or
refractory non-Hodgkin's lymphoma. II. Determine the feasibility of pretransplantation
cytoreduction with a regimen of high-dose cytarabine, cisplatin, and dexamethasone in this
patient population. III. Determine the feasibility of posttransplantation radiotherapy given
to sites of residual disease (involved-field "boost" irradiation) in this patient
population.
OUTLINE: Patients are stratified by disease status (refractory vs relapsed). Autologous bone
marrow is harvested before cytoreduction or involved field radiotherapy (IFRT). Patients
with marrow involvement who achieve marrow complete response after cytoreduction undergo
harvest of bone marrow before IFRT. Patients receive cytoreduction comprising high-dose
cytarabine IV over 1 hour every 12 hours, cisplatin IV over 10 hours, and dexamethasone
three times daily on days 1 and 2. At 3 weeks, a second course is administered if tumor
reduction is at least 25% and in the absence of unacceptable toxicity. Patients with
involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active
disease sites, at least 90% of which can be treated with IFRT, undergo IFRT 5 days a week
for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow. Within
10 days after completion of IFRT, patients receive etoposide IV over 26 hours beginning on
day -7, cyclophosphamide IV over 2 hours on days -6 to -4, and total body irradiation twice
daily on days -3 and -2 and once on day -1. Bone marrow is reinfused on day 0. Eligible
patients with residual disease at 3 months after transplantation undergo involved field
"boost" irradiation to sites of residual disease.
PROJECTED ACCRUAL: Approximately 50 patients (25 per stratum) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
Robert F. Taylor, MD
Study Chair
St. Luke's Medical Center
United States: Federal Government
CDR0000077128
NCT00002481
March 1990
Name | Location |
---|---|
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |