Non Hodgkin Lymphoma Clinical Trial
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV 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.
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.
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
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There are 66 Locations for this study
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Fremont California, 94538, United States
Hayward California, 94545, United States
Oakland California, 94611, United States
Sacramento California, 95823, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
San Rafael California, 94903, United States
Santa Clara California, 95051, United States
Santa Rosa California, 95403, United States
South San Francisco California, 94080, United States
Stockton California, 95210, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Hartford Connecticut, 06105, United States
Orlando Florida, 32806, United States
Decatur Illinois, 62526, United States
Maywood Illinois, 60153, United States
Springfield Illinois, 62781, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66606, United States
Lexington Kentucky, 40536, United States
Monroe Louisiana, 71210, United States
Shreveport Louisiana, 71105, United States
Shreveport Louisiana, 71130, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Detroit Michigan, 48201, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Goldsboro North Carolina, 27534, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Kennewick Washington, 99336, United States
Mt. Vernon Washington, 98273, United States
Poulsbo Washington, 98370, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Spokane Washington, 99218, United States
Wenatchee Washington, 98801, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
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