Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

February 2, 2006 updated 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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Fullerton, California, United States, 92835
        • Virginia K. Crosson Cancer Center
      • Glendale, California, United States, 91204
        • Pacific Shores Medical Group
      • Glendora, California, United States, 91741
        • Wilshire Oncology Medical Group
      • Greenbrae, California, United States, 94904
        • California Cancer Care Inc.
      • Huntington Beach, California, United States, 92648
        • Pacific Shores Medical Group
      • Lompoc, California, United States, 93438
        • Santa Barbara Hematology Oncology Medical Group
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Alamitos, California, United States, 90720
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095
        • UCLS Medical Center
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Mission Hills, California, United States, 91345
        • North Valley Hematology-Oncology Medical Group
      • Newport Beach, California, United States, 92658
        • Hoag Cancer Center
      • Northridge, California, United States, 91328
        • North Valley Hematology/Oncology Medical Group
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Pasadena, California, United States, 91105
        • UCLA Medical Group/Pasadena Oncology
      • Pasadena, California, United States, 91105
        • Wilshire Oncology Medical Group
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Group
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Rancho Cucamonga, California, United States, 91730
        • Wilshire Oncology Medical Group
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Meidcal Group, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group, Inc.
      • Santa Barbara, California, United States, 93105
        • Sansum Santa Barbara Foundation Medical Clinic
      • Santa Maria, California, United States, 93454
        • Santa Barbara Hematology Oncology Medical Group
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Solvang, California, United States, 93463
        • Santa Barbara Hematology Oncology Medical Group
      • Torrance, California, United States, 90505
        • Cancer Care Associates Medical Group, Inc.
      • Valencia, California, United States, 91355
        • UCLA/Santa Clarita Valley Cancer Center
      • Ventura, California, United States, 93003
        • Ventura County Hematology-Oncology Specialists
      • Vista, California, United States, 92083
        • San Diego Cancer Center Medical Group
      • West Covina, California, United States, 91790
        • Wilshire Oncology Medical Group
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • Division of Hematology/Oncology, University of Miami, School of Medicine
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical School
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists,S.C.
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana Oncology and Hematology Consultants
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Hematology And Oncology Specialists, Llc
      • Shreveport, Louisiana, United States, 71130
        • Louisiana State University Health Sciences Center and VA
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine & Blood Disorders
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northern New Jersey Cancer Associates
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • New Rochelle, New York, United States, 10801
        • Advanced Oncology Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University/New York Presbyterian Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27858-4354
        • East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Germantown Cancer Foundation
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiron Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2002

First Submitted That Met QC Criteria

September 13, 2002

First Posted (ESTIMATE)

September 16, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2006

Last Update Submitted That Met QC Criteria

February 2, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL2NHL03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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