Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving rituximab together with combination chemotherapy may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large
      B-cell non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 2-year progression-free survival (PFS) rate after treatment with
           rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage
           II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron
           emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide,
           vincristine, doxorubicin hydrochloride, and prednisone.

      Secondary

        -  Determine the proportion of mid-treatment PET-positive patients who become PET-negative
           after 4 courses of R-ICE.

        -  Determine the PFS of mid-treatment PET-negative patients treated with these regimens.

        -  Determine the overall survival of patients treated with these regimens.

        -  Determine the toxicity of these regimens in these patients.

      OUTLINE:

        -  Rituximab and Combination Chemotherapy (R-CHOP: R= Rituximab, C= Cyclophosphamide, H=
           Doxorubicin Hydrochloride (Hydroxydaunomycin), O= Vincristine Sulfate (Oncovin), P=
           Prednisone): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin
           hydrochloride IV, and vincristine IV on day 1, and oral prednisone once daily on days
           1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression
           or unacceptable toxicity. Patients undergo fludeoxyglucose F18 positron emission
           tomography (PET) scanning and conventional restaging during course 3. Based on the PET
           results, patients are assigned to 1 of 2 treatment groups.

             -  Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the
                absence of disease progression or unacceptable toxicity.

             -  Group II (PET positive): Patients receive Rituximab 375 mg/m2 IV Day 1, Ifosfamide
                5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2,
                Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day
                2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil
                count (ANC) recovery every 14 days for 4 courses in the absence of disease
                progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 10 years from the
      date of study entry.

      ACCRUAL: A total of 100 patients were accrued for this study.
    

Intervention name(s): filgrastim; rituximab; carboplatin; cyclophosphamide; doxorubicin hydrochloride; etoposide; ifosfamide; prednisone; vincristine
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Given subcutaneously or intravenous bolus.; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Taken orally; Given IV
Other intervention name(s): G-CSF, Neupogen, recombinant-methionyl human granulocyte-colony stimulating; factor, granulocyte colony-stimulating factor, r-metHuG-CSF.; IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan.; CBDCA, Paraplatin, JM-8, NSC #241240.; Cytoxan, Neosar, CTX, CPM.; Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin,; hydroxydaunomycin, ADR.; VP-16, VePesid, epipodophyllotoxin; Isophosphamide, Ifex , Mitoxan , Holoxan , Naxamide ' NSC # 109724.; Deltasone, Orasone, Medicorten, Panasol-S, Liquid-Pred, others.; Oncovin, Vincasar PFS vincristine sulfate, VCR, leucocristine, LCR.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Ifosfamide; Rituximab; Carboplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Podophyllotoxin; Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma