S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral 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.

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