S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: etoposide; Drug: gemcitabine; Drug: methylprednisolone; Drug: cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00109928

S0350 (Other Identifier)

CDR0000425643

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

PEGS Treatment

Experimental group

Description:

VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1

Treatment:

Drug: methylprednisolone

Drug: cisplatin

Drug: gemcitabine

Drug: etoposide