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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00109928 |
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 |
Estimated Enrollment: | 55 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of peripheral T-cell non-Hodgkin's lymphoma
The following histologies are not eligible:
ALCL with CD30, ALK, and EMA expression
Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Daruka Mahadevan, MD, PhD | University of Arizona |
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 |
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 |
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 |
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 |