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

Condition(s) targeted: Lymphoma, Non-Hodgkin

Intervention: Recombinant Human Interleukin-2 and Rituximab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Chiron Corporation

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.

Study design: Treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

ACRC/Arizona Clinical Research Center, Inc., Tucson, Arizona 85712, United States

John Wayne Cancer Institute, Santa Monica, California 90404, United States

Hoag Cancer Center, Newport Beach, California 92658, United States

UC Davis Cancer Center, Sacramento, California 95817, United States

California Cancer Medical Center, West Covina, California 91790, United States

Stanford University Medical Center, Stanford, California 94305-5151, United States

Washington Cancer Institute, Washington, District of Columbia 20010, United States

Georgetown University Medical Center, Lombardi Cancer Center, Washington, District of Columbia 20007, United States

Division of Hematology/Oncology, University of Miami School of Medicine, Miami, Florida 333136, United States

Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611, United States

Oncology Specialists, S.C., Park Ridge, Illinois 60068, United States

Rush Cancer Institute, Chicago, Illinois 60612, United States

Cancer Care Center, Bloomington, Indiana 47403, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky 40207, United States

Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology, Shreveport, Louisiana 71130, United States

Arch Medical Group, LLC, St. Louis, Missouri 63141, United States

Kansas City Oncology and Hematology Group, Kansas City, Missouri 64111, United States

Dartmouth-Hitchcock-Medical Center, Lebanon, New Hampshire 03756, United States

Our Lady of Mercy Medical Center, Comprehensive Cancer Center, Bronx, New York 10466, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10021, United States

East Carolina University School of Medicine/ Division of Hematology/Oncology, Greenville, North Carolina 27858, United States

Roger Maris Health System, Fargo, North Dakota 58122, United States

Oncology Hematology Care Inc., Cincinnati, Ohio 45242, United States

Hematology /Oncology Consultants Inc., Columbus, Ohio 43235, United States

Gabrail Cancer Center, Canton, Ohio 44718, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Oregon Heath and Science University, Portland, Oregon 97201, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29615, United States

Germantown Cancer Center, Germantown, Tennessee 38138, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

Cancer Specialists of South Texas, P.A., Corpus Christi, Texas 78412, United States

Virginia Cancer Institute, Richmond, Virginia 23230, United States

Last updated: February 2, 2006