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.

Condition	Treatment or Intervention	Phase
recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse large cell lymphoma anaplastic large cell lymphoma	Drug: carboplatin  Drug: etoposide  Drug: filgrastim  Drug: ifosfamide  Drug: rituximab	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   72 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven non-Hodgkin's lymphoma that is in first relapse or refractory to primary therapy; Eligible types: Diffuse large cell Immunoblastic; Anaplastic large cell
• Eligible for autologous peripheral blood stem cell transplantation
• CD20-positive disease
• Measurable disease
• No brain parenchyma involvement

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; Prior rituximab allowed
• Chemotherapy: No prior carboplatin or cisplatin
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 to 72
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 50,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL unless due to Gilbert's disease; No chronic or persistent hepatitis; Hepatitis B surface antigen negative
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min; No chronic renal insufficiency
• Cardiovascular: Normal baseline cardiac function; Ejection fraction at least 50% by echocardiogram or MUGA scan; No myocardial infarction within the past 6 months; No unstable angina; No cardiac arrhythmias except chronic atrial fibrillation
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; HIV negative; No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No uncontrolled infection

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Craig Moskowitz,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067785; MSKCC-99092; NCI-G00-1774
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005631
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08