NCT00109928

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

Official Title:

Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's 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

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

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: cisplatin
    • Description:
    • Arm Group Labels: PEGS Treatment
    • Type: DRUG
    • Name: etoposide
    • Description:
    • Arm Group Labels: PEGS Treatment
    • Type: DRUG
    • Name: gemcitabine
    • Description:
    • Arm Group Labels: PEGS Treatment
    • Type: DRUG
    • Name: methylprednisolone
    • Description:
    • Arm Group Labels: PEGS Treatment
Sponsor
  • SWOG Cancer Research Network