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Status:

COMPLETED

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

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 s...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT00109928

    Start Date

    September 1 2005

    End Date

    April 1 2014

    Last Update

    October 1 2014

    Active Locations (77)

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    Page 1 of 20 (77 locations)

    1

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024

    2

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Kaiser Permanente - Fremont

    Fremont, California, United States, 94538

    4

    Kaiser Permanente Medical Center - Hayward

    Hayward, California, United States, 94545