S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: filgrastim; rituximab; cyclophosphamide; cytarabine; dexamethasone; doxorubicin; leucovorin; methotrexate; vincristine
Intervention description: 5 ug/kg; 375 mg/m^2 on day 1 of cycles 1-6; 300 mg/m^2 on days 2-4 of cycles 1,3,5,7; 12 g/m^2 over days 3-4 of cycles 2,4,6,8; 40 mg on days 2-5 and 12-15 of cycles 1,3,5,7; 16.6 mg/m^2/day for days 5-7 of cycles 1,3,5,7; 170 mg over days 3-5 of cycles 2,4,6,8; 1000 mg/m^2 over days 2-3 of cycles 2,4,6,8; 1.4 mg/m^2 on days 5 and 12 of cycles 1,3,5,7
Intervention MeSH terms: Leucovorin; Cytarabine; Dexamethasone; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: stage III mantle cell lymphoma; stage IV mantle cell lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
      and either kill them or deliver cancer-killing substances to them without harming normal
      cells. Combining rituximab with chemotherapy may kill more cancer cells.

      PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with
      rituximab in treating patients who have newly diagnosed mantle cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of
             the following histologic subtypes:

               -  Nodular

               -  Diffuse

               -  Mantle zone

               -  Blastic

          -  Newly diagnosed and previously untreated disease

          -  Bidimensionally measurable disease

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 69

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 100,000/mm^3 (50,000/mm^3 if marrow involvement present)

        Hepatic:

          -  Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)

        Renal:

          -  Creatinine no greater than 2.0 mg/dL

          -  Creatinine clearance greater than 50 mL/min

        Cardiovascular:

          -  Ejection fraction at least 50% by MUGA or 2-D echocardiogram

          -  No significant abnormalities by EKG

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Willing to receive blood product transfusions

          -  No known sensitivity to E. coli-derived proteins

          -  No known AIDS syndrome or HIV-associated complex

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior monoclonal antibody therapy

        Chemotherapy:

          -  No prior chemotherapy for lymphoma

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy for lymphoma

        Surgery:

          -  Not specified