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

Sponsor

Chiron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00045864

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin	Drug: Recombinant Human Interleukin-2 and Rituximab	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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