Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma. - Full Text View

Sponsor:	Chiron Corporation
Information provided by:	Chiron Corporation
ClinicalTrials.gov Identifier:	NCT00045864

Purpose

The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: Recombinant Human Interleukin-2 and Rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Interleukin-2 Aldesleukin Rituximab

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens.

Exclusion:

Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment
Clinically significant pulmonary dysfunction.
Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment).
Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
History of autoimmune disease.
History of positive serology for human immunodeficiency virus (HIV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045864

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Locations

United States, Arizona
ACRC/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85712
United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Hoag Cancer Center
Newport Beach, California, United States, 92658
UC Davis Cancer Center
Sacramento, California, United States, 95817
California Cancer Medical Center
West Covina, California, United States, 91790
Stanford University Medical Center
Stanford, California, United States, 94305-5151
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
Georgetown University Medical Center, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Division of Hematology/Oncology, University of Miami School of Medicine
Miami, Florida, United States, 333136
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Rush Cancer Institute
Chicago, Illinois, United States, 60612
United States, Indiana
Cancer Care Center
Bloomington, Indiana, United States, 47403
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
Shreveport, Louisiana, United States, 71130
United States, Missouri
Arch Medical Group, LLC
St. Louis, Missouri, United States, 63141
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Dartmouth-Hitchcock-Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Our Lady of Mercy Medical Center, Comprehensive Cancer Center
Bronx, New York, United States, 10466
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
East Carolina University School of Medicine/ Division of Hematology/Oncology
Greenville, North Carolina, United States, 27858
United States, North Dakota
Roger Maris Health System
Fargo, North Dakota, United States, 58122
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
Hematology /Oncology Consultants Inc.
Columbus, Ohio, United States, 43235
Gabrail Cancer Center
Canton, Ohio, United States, 44718
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Heath and Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
Germantown Cancer Center
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, United States, 78412
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230

Sponsors and Collaborators

Chiron Corporation

More Information

No publications provided

Study ID Numbers:	IL2NHL05
Study First Received:	September 12, 2002
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00045864 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Chiron Corporation:

Intermediate and High-Grade Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Aldesleukin

Anti-Retroviral Agents
Sensory System Agents
Analgesics, Non-Narcotic
Interleukin-2
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009