s0350 combination chemotherapy in treating patients with newly diagnosed stage ii, stage iii, or stage iv peripheral t-cell non-hodgkin's lymphoma

Conditions: 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.

objectives: primary * determine 2-year overall survival of patients with newly diagnosed, bulky stage ii or stage iii or iv peripheral t-cell non-hodgkin's lymphoma treated with cisplatin, etoposide, gemcitabine, and methylprednisolone. secondary * determine the toxicity of this regimen in these patients. * determine the response rate (complete unconfirmed response, complete response, and partial response) in patients treated with this regimen. * determine progression-free survival of patients treated with this regimen. outline: this is a pilot, multicenter study. patients receive cisplatin iv over 30-60 minutes, etoposide iv over 30-60 minutes, and methylprednisolone iv over 5 minutes on days 1-4. patients also receive gemcitabine iv over 30-60 minutes on day 1. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed at 3-6 weeks, 3 months, and then every 6 months for up to 3 years. projected accrual: a total of 55 patients will be accrued for this study within 3 years.

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

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