S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell
Intervention: cisplatin; etoposide; gemcitabine; methylprednisolone
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Gemcitabine; Etoposide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; 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; anaplastic large cell lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and
      methylprednisolone, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Giving more than one drug (combination
      chemotherapy) may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
      patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of peripheral T-cell non-Hodgkin's lymphoma

               -  Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a
                  non-platinum based chemotherapy (e.g., CHOP)

               -  Bulky stage II or stage III or IV disease

          -  The following histologies are not eligible:

               -  T-cell prolymphocytic leukemia

               -  T-cell large granular lymphocytic leukemia

               -  Any NK-cell leukemia

               -  Adult T-cell leukemia/lymphoma

               -  Mycosis fungoides/Sézary syndrome

               -  Lymphomatoid papulosis

               -  Nasal-type extranodal NK/T-cell lymphoma

               -  Enteropathy-type T-cell lymphoma

               -  Hepatosplenic T-cell lymphoma

               -  Subcutaneous panniculitis-like T-cell lymphoma

               -  Angioimmunoblastic T-cell lymphoma

               -  Primary cutaneous anaplastic large cell lymphoma (ALCL)

               -  ALCL with CD30, ALK, and EMA expression

                    -  ALCL morphology that fails to express ALK or EMA allowed provided T-cell
                       lineage is confirmed by immunotyping or genetic testing

          -  Bidimensionally measurable disease

          -  Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the
             original diagnostic specimen available

               -  Needle aspiration or cytology is not considered adequate samples

          -  No clinical evidence of Central nervous system (CNS) involvement by lymphoma

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 2 times upper limit of normal

        Renal

          -  Creatinine clearance ≥ 30 mL/min

        Cardiovascular

          -  No history of congestive heart failure

          -  No history of myocardial infarction

          -  No history of unstable angina

          -  No history of asymptomatic arrhythmias

          -  Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with
             questionable cardiac history)

          -  No other history of impaired cardiac status

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known HIV positivity

          -  Mild clinical hearing loss allowed provided patient is willing to accept the potential
             for worsening of hearing loss

          -  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

          -  Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and
             pelvis within the past 28 days

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 3 weeks since prior biologic therapy

          -  No concurrent routine use of bone marrow colony-stimulating factors

        Chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for this cancer

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  No prior cytotoxic therapy for this cancer

          -  Concurrent enrollment in SWOG-8819 or SWOG-8947 allowed