Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: filgrastim; rituximab; carboplatin; cyclophosphamide; doxorubicin hydrochloride; etoposide; ifosfamide; prednisone; vincristine sulfate; peripheral blood stem cell transplantation; radiation therapy
Intervention MeSH terms: Prednisone; Cyclophosphamide; Ifosfamide; Rituximab; Carboplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large 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 chemotherapy with monoclonal antibody therapy, total-body irradiation, and
      peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy
      drugs and kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed
      by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral
      stem cell transplant works in treating patients with lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed aggressive diffuse large B-cell lymphoma

          -  CD20-positive disease

          -  Age-adjusted International Prognostic Index II or III defined by the presence of at
             least 1 of the following:

               -  Karnofsky performance status 10-70%

               -  Lactate dehydrogenase greater than 200 U/L

               -  Stage III or IV disease

          -  Positron emission tomography avid measurable disease

          -  No CNS involvement

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 64

        Performance status:

          -  See Disease Characteristics

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count greater than 1,000/mm^3

          -  Platelet count greater than 50,000/mm^3

        Hepatic:

          -  Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern
             consistent with Gilbert's disease

          -  Hepatitis B surface antigen and hepatitis C antibody negative

          -  No chronic, active, or persistent hepatitis

        Renal:

          -  Creatinine no greater than 1.5 mg/dL OR

          -  Creatinine clearance greater than 60 mL/min

          -  No chronic renal insufficiency

        Cardiovascular:

          -  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 medical illness that would preclude study

          -  No uncontrolled infection

          -  No other malignancy within the past 5 years except curatively treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior biologic therapy for malignancy

        Chemotherapy:

          -  No prior chemotherapy for malignancy

        Endocrine therapy:

          -  Prior steroids allowed if received no more than 1 week of therapy

        Radiotherapy:

          -  No prior radiotherapy for malignancy

        Surgery:

          -  No prior surgery for malignancy

        Other:

          -  No other prior therapy for malignancy