Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus Taxol/Cisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocyte Leukemia, Who Have Received < or = 12 Months of Standard Therapy
OBJECTIVES: I. Evaluate the complete and partial response rates to treatment with peripheral
blood stem cell supported high dose carmustine and melphalan followed by consolidation
therapy with dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) and dexamethasone,
paclitaxel, and cisplatin in patients with poor prognosis low grade non-Hodgkin's lymphoma
or chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy. II.
Evaluate the incidence of early deaths (less than 60 days posttransplant) in comparison with
historical experience in this patient population. III. Evaluate the toxicity of
posttransplantation chemotherapy with DCEP and dexamethasone, paclitaxel, and cisplatin in
these patients.
OUTLINE: Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1
followed by peripheral blood stem cell infusion on day 0. At 3 months and 9 months after
completion of autologous transplantation, patients receive cyclophosphamide, etoposide, and
cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4
days. At 6 and 12 months after completion of autologous transplantation, patients receive
dexamethasone orally every day for 4 days, paclitaxel continuous IV infusion over 6 hours on
day 2, and cisplatin continuous IV infusion over 24 hours on day 3.
PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 1-2.5 years.
Interventional
Primary Purpose: Treatment
Barry R. Meisenberg, MD
Study Chair
University of Maryland Greenebaum Cancer Center
United States: Federal Government
CDR0000066407
NCT00003402
January 1999
December 2002
Name | Location |
---|---|
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |