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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00109928

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 66 Locations for this study

See Locations Near You

Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson Arizona, 85724, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Kaiser Permanente - Fremont
Fremont California, 94538, United States
Kaiser Permanente Medical Center - Hayward
Hayward California, 94545, United States
Kaiser Permanente Medical Center - Oakland
Oakland California, 94611, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento California, 95823, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco California, 94115, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose California, 95119, United States
Kaiser Foundation Hospital - San Rafael
San Rafael California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara California, 95051, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa California, 95403, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente Medical Facility - Stockton
Stockton California, 95210, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek California, 94596, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
M.D. Anderson Cancer Center at Orlando
Orlando Florida, 32806, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66606, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
Louisiana State University Health Sciences Center - Monroe
Monroe Louisiana, 71210, United States
Highland Clinic
Shreveport Louisiana, 71105, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport Louisiana, 71130, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Columbia Basin Hematology
Kennewick Washington, 99336, United States
Skagit Valley Hospital Cancer Care Center
Mt. Vernon Washington, 98273, United States
Harrison Poulsbo Hematology and Onocology
Poulsbo Washington, 98370, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Evergreen Hematology and Oncology, PS
Spokane Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00109928

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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