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

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Trial Identification

Brief Title: 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

Study ID: NCT00109928

Conditions

Lymphoma

Study Description

Brief 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.

Detailed 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Kaiser Permanente - Fremont, Fremont, California, United States

Kaiser Permanente Medical Center - Hayward, Hayward, California, United States

Kaiser Permanente Medical Center - Oakland, Oakland, California, United States

South Sacramento Kaiser-Permanente Medical Center, Sacramento, California, United States

Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Teresa, San Jose, California, United States

Kaiser Foundation Hospital - San Rafael, San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, United States

Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa, California, United States

Kaiser Permanente Medical Center - South San Francisco, South San Francisco, California, United States

Kaiser Permanente Medical Facility - Stockton, Stockton, California, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States

Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek, California, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States

Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States

Cotton-O'Neil Cancer Center, Topeka, Kansas, United States

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States

Louisiana State University Health Sciences Center - Monroe, Monroe, Louisiana, United States

Highland Clinic, Shreveport, Louisiana, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Foote Memorial Hospital, Jackson, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary Mercy Hospital, Livonia, Michigan, United States

St. Joseph Mercy Oakland, Pontiac, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

, Great Falls, Montana, United States

Northern Montana Hospital, Havre, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Glacier Oncology, PLLC, Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States

Guardian Oncology and Center for Wellness, Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Interlakes Oncology/Hematology PC, Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

St. Joseph Cancer Center, Bellingham, Washington, United States

Olympic Hematology and Oncology, Bremerton, Washington, United States

Columbia Basin Hematology, Kennewick, Washington, United States

Skagit Valley Hospital Cancer Care Center, Mt. Vernon, Washington, United States

Harrison Poulsbo Hematology and Onocology, Poulsbo, Washington, United States

Harborview Medical Center, Seattle, Washington, United States

Minor and James Medical, PLLC, Seattle, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Group Health Central Hospital, Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States

Polyclinic First Hill, Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States

Cancer Care Northwest - Spokane South, Spokane, Washington, United States

Evergreen Hematology and Oncology, PS, Spokane, Washington, United States

Wenatchee Valley Medical Center, Wenatchee, Washington, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Contact Details

Name: Daruka Mahadevan, MD, PhD

Affiliation: University of Arizona

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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