SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab; CHOP regimen; carmustine; cyclophosphamide; doxorubicin hydrochloride; etoposide; prednisone; vincristine sulfate; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation; radiation therapy
Intervention description: 375 mg/m2 IV every 21 days
Intervention MeSH terms: Prednisone; Cyclophosphamide; Carmustine; Rituximab; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult Burkitt lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
      chemotherapy and radiation and kill more cancer cells. It is not yet known whether
      chemoradiotherapy plus peripheral stem cell transplantation is more effective than
      combination chemotherapy alone in treating non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem
      cell transplantation to see how well they work compared to combination chemotherapy in
      treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma

          -  Ann Arbor classification of "bulky" stage II, III, or IV

          -  Must be classified as high-intermediate or high-risk according to International Age
             Adjusted Index

          -  Bidimensionally measurable disease

          -  No lymphoblastic, transformed, or mantle cell lymphomas

          -  No CNS involvement by lymphoma

          -  CD20 status confirmed by immunocytochemistry or flow cytometry

          -  Must have either bilateral or unilateral bone marrow aspiration and biopsy ≥ 42 days
             before first course of cyclophosphamide, doxorubicin, vincristine, and prednisone
             (CHOP) therapy (or CHOP plus rituximab [CHOP-R] for CD20+ disease) OR within 42 days
             prior to registration if CHOP/CHOP-R therapy has not begun

          -  Must have bilateral bone marrow aspiration and biopsy within 28 days of randomization

               -  Bone marrow involvement with lymphoma is allowed, provided there is an
                  improvement of at least 50% if used as an evaluable site of disease

          -  No prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia NOTE: A
             new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
             The terminology of "indolent" or "aggressive" lymphoma will replace the former
             terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
             uses the former terminology.

        PATIENT CHARACTERISTICS:

        Age:

          -  15 to 65

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  No nonlymphoma-related hepatic dysfunction

        Renal:

          -  Creatinine no greater than 2 times ULN

          -  Creatinine clearance at least 60 mL/min

          -  No nonlymphoma-related renal dysfunction

          -  No history of grade 3 hemorrhagic cystitis due to cyclophosphamide

        Cardiovascular:

          -  No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia
             requiring therapy

          -  MUGA scan or 2-D echocardiogram required if patient's history is questionable

          -  Ejection fraction normal

        Pulmonary:

          -  DLCO or FEV_1 at least 60% of predicted

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective 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 allergy to etoposide

          -  No active bacterial, fungal, or viral infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior monoclonal antibody therapy for lymphoma except if included in a single
             course of CHOP/CHOP-R

        Chemotherapy:

          -  No prior chemotherapy for lymphoma except for a single course of CHOP/CHOP-R* NOTE:
             *Prednisone or other corticosteroids not considered prior chemotherapy

        Endocrine therapy:

          -  See Chemotherapy

          -  Prior corticosteroids allowed

        Radiotherapy:

          -  No prior radiotherapy for lymphoma

          -  No prior thoracic radiotherapy or radiotherapy greater than 2,000 cGy to any other
             site

        Surgery:

          -  Not specified