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

NCT ID: NCT00109928

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2014-04-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEGS Treatment

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

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

gemcitabine

Intervention Type: DRUG

methylprednisolone

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

gemcitabine

Intervention Type: DRUG

methylprednisolone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daruka Mahadevan, MD, PhD

Role: STUDY_CHAIR

University of Arizona

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

Mount 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

Countries

United States

References

Mahadevan D, Unger JM, Spier CM, Persky DO, Young F, LeBlanc M, Fisher RI, Miller TP. Phase 2 trial of combined cisplatin, etoposide, gemcitabine, and methylprednisolone (PEGS) in peripheral T-cell non-Hodgkin lymphoma: Southwest Oncology Group Study S0350. Cancer. 2013 Jan 15;119(2):371-9. doi: 10.1002/cncr.27733. Epub 2012 Jul 25.

Reference Type: RESULT

PMID: 22833464 (View on PubMed)

Other Identifiers

S0350

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000425643

Identifier Type: -

Identifier Source: org_study_id