Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2009
First Received: May 3, 2005   Last Updated: August 20, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109928
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: cisplatin
Drug: etoposide
Drug: gemcitabine hydrochloride
Drug: methylprednisolone
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 2 years [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate (complete unconfirmed, complete, and partial) [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: September 2005
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109928

  Show 80 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Daruka Mahadevan, MD, PhD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers: CDR0000425643, SWOG-S0350
Study First Received: May 3, 2005
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00109928     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
anaplastic large cell lymphoma

Study placed in the following topic categories:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Etoposide phosphate
Lymphoma, Small Cleaved-cell, Diffuse
Cisplatin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Gemcitabine
Lymphoma, Large-cell
Lymphoma
Etoposide
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Methylprednisolone acetate
Immunosuppressive Agents
Antiviral Agents
Glucocorticoids
Lymphatic Diseases
Radiation-Sensitizing Agents

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Cisplatin
Lymphoma, T-Cell
Therapeutic Uses
Gemcitabine
Etoposide
Lymphoma
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on September 03, 2009