Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy in treating patients who have relapsed or refractory large cell lymphoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Cytoreduction and Stem Cell Mobilization With Rituximab and ICE for Patients With Refractory or Relapsed CD20+ B-Cell IGL Eligible for ASCT: The RICE Protocol|
|Study Start Date:||November 1999|
|Study Completion Date:||November 2002|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the complete response rate in patients with relapsed or refractory CD20-positive diffuse large cell, immunoblastic, or anaplastic large cell lymphoma treated with cytoreduction and mobilization with rituximab, ifosfamide, carboplatin, and etoposide (RICE). II. Assess the ability of this regimen to deplete the stem cell harvest of B-cells and tumor cells in these patients. III. Assess the efficacy of this regimen to mobilize peripheral blood progenitor cells in these patients. IV. Assess the safety and toxicity of this regimen in these patients.
OUTLINE: Cytoreduction and mobilization: Patients receive ifosfamide IV over 24 hours and carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5. Chemotherapy repeats every 2 weeks for 3 courses. Patients receive rituximab IV on day -2 before initiation of chemotherapy and on day 1 of each course of chemotherapy. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily on days 7-14 of each course of chemotherapy. Patients with complete or partial response after completion of course 3 continue to receive G-CSF SC daily until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. If sufficient numbers of CD34+ cells are not obtained, patients undergo bone marrow harvest.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005631
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Craig Moskowitz, MD||Memorial Sloan-Kettering Cancer Center|