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Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
This study has been completed.
First Received: September 12, 2002   Last Updated: February 2, 2006   History of Changes
Sponsor: Chiron Corporation
Information provided by: Chiron Corporation
ClinicalTrials.gov Identifier: NCT00045877
  Purpose

The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.


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

Study Type: Interventional
Study Design: Treatment

Resource links provided by NLM:

  Eligibility

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

Diagnosis and disease status:

  • Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded.
  • Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting < 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site.

Exclusion:

  • Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
  • HIV positive.
  • Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
  • Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
  • If cardiac ejection fraction has been measured, it must be greater than 50%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045877

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
UC Davis Cancer Center
Sacramento, California, United States, 95817
California Cancer Care Inc.
Greenbrae, California, United States, 94904
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Hoag Cancer Center
Newport Beach, California, United States, 92658
Southwest Cancer Care
Poway, California, United States, 92064
UCLS Medical Center
Los Angeles, California, United States, 90095
San Diego Cancer Center Medical Group
Vista, California, United States, 92083
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology Medical Group
Lompoc, California, United States, 93438
Santa Barbara Hematology Oncology Medical Group
Solvang, California, United States, 93463
Santa Barbara Hematology Oncology Medical Group
Santa Maria, California, United States, 93454
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, United States, 91355
Cancer Care Associates Meidcal Group, Inc.
Redondo Beach, California, United States, 90277
Cancer Care Associates Medical Group, Inc.
Torrance, California, United States, 90505
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, United States, 93105
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Ventura County Hematology-Oncology Specialists
Ventura, California, United States, 93003
UCLA Medical Group/Pasadena Oncology
Pasadena, California, United States, 91105
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91328
Facey Medical Foundation
Mission Hills, California, United States, 91345
North Valley Hematology-Oncology Medical Group
Mission Hills, California, United States, 91345
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Pacific Shores Medical Group
Los Alamitos, California, United States, 90720
Pacific Shores Medical Group
Glendale, California, United States, 91204
Pacific Shores Medical Group
Huntington Beach, California, United States, 92648
Wilshire Oncology Medical Group
Pomona, California, United States, 91767
Wilshire Oncology Medical Group
Rancho Cucamonga, California, United States, 91730
Wilshire Oncology Medical Group
West Covina, California, United States, 91790
Wilshire Oncology Medical Group
Pasadena, California, United States, 91105
Wilshire Oncology Medical Group
Glendora, California, United States, 91741
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
California Oncology of the Central Valley
Fresno, California, United States, 93710
United States, Connecticut
Whittingham Cancer Center
Norwalk, Connecticut, United States, 06856
United States, Florida
Division of Hematology/Oncology, University of Miami, School of Medicine
Miami, Florida, United States, 33136
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
Oncology Specialists,S.C.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Cancer Care Center
Bloomington, Indiana, United States, 47403
Indiana Oncology and Hematology Consultants
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Louisiana State University Health Sciences Center and VA
Shreveport, Louisiana, United States, 71130
Hematology and Oncology Specialists, LLC
New Orleans, Louisiana, United States, 70115
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States, 04074
United States, Missouri
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States, 64111
United States, Montana
Benefis Healthcare
Great Falls, Montana, United States, 59405
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Northern New Jersey Cancer Associates
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
Advanced Oncology Associates
New Rochelle, New York, United States, 10801
Erie County Medical Center
Buffalo, New York, United States, 14215
United States, North Carolina
East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
Greenville, North Carolina, United States, 27858-4354
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, United States, 43210
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 Health & Science University
Portland, Oregon, United States, 97201
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Germantown Cancer Foundation
Germantown, Tennessee, United States, 38138
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Chiron Corporation
  More Information

No publications provided

Study ID Numbers: IL2NHL03
Study First Received: September 12, 2002
Last Updated: February 2, 2006
ClinicalTrials.gov Identifier: NCT00045877     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Chiron Corporation:
Low-Grade or Follicular 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 25, 2009