Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
|Leukemia Lymphoma||Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: dexamethasone Drug: etoposide Drug: melphalan Drug: paclitaxel Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||January 1999|
|Study Completion Date:||December 2002|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003402
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Study Chair:||Barry R. Meisenberg, MD||University of Maryland Greenebaum Cancer Center|