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

NCT ID: NCT00045877

Last Updated: 2006-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Recombinant Human Interleukin-2 and Rituximab

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiron Corporation

INDUSTRY

Sponsor Role lead

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

California Oncology of the Central Valley

Fresno, California, United States

Site Status

Virginia K. Crosson Cancer Center

Fullerton, California, United States

Site Status

Pacific Shores Medical Group

Glendale, California, United States

Site Status

Wilshire Oncology Medical Group

Glendora, California, United States

Site Status

California Cancer Care Inc.

Greenbrae, California, United States

Site Status

Pacific Shores Medical Group

Huntington Beach, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group

Lompoc, California, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

Pacific Shores Medical Group

Los Alamitos, California, United States

Site Status

UCLS Medical Center

Los Angeles, California, United States

Site Status

Facey Medical Foundation

Mission Hills, California, United States

Site Status

North Valley Hematology-Oncology Medical Group

Mission Hills, California, United States

Site Status

Hoag Cancer Center

Newport Beach, California, United States

Site Status

North Valley Hematology/Oncology Medical Group

Northridge, California, United States

Site Status

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Site Status

UCLA Medical Group/Pasadena Oncology

Pasadena, California, United States

Site Status

Wilshire Oncology Medical Group

Pasadena, California, United States

Site Status

Wilshire Oncology Medical Group

Pomona, California, United States

Site Status

Southwest Cancer Care

Poway, California, United States

Site Status

Wilshire Oncology Medical Group

Rancho Cucamonga, California, United States

Site Status

Cancer Care Associates Meidcal Group, Inc.

Redondo Beach, California, United States

Site Status

UC Davis Cancer Center

Sacramento, California, United States

Site Status

Sansum Santa Barbara Foundation Medical Clinic

Santa Barbara, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group

Santa Maria, California, United States

Site Status

John Wayne Cancer Institute

Santa Monica, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group

Solvang, California, United States

Site Status

Cancer Care Associates Medical Group, Inc.

Torrance, California, United States

Site Status

UCLA/Santa Clarita Valley Cancer Center

Valencia, California, United States

Site Status

Ventura County Hematology-Oncology Specialists

Ventura, California, United States

Site Status

San Diego Cancer Center Medical Group

Vista, California, United States

Site Status

Wilshire Oncology Medical Group

West Covina, California, United States

Site Status

Whittingham Cancer Center

Norwalk, Connecticut, United States

Site Status

Division of Hematology/Oncology, University of Miami, School of Medicine

Miami, Florida, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

Northwestern University Medical School

Chicago, Illinois, United States

Site Status

Oncology Specialists,S.C.

Park Ridge, Illinois, United States

Site Status

Cancer Care Center

Bloomington, Indiana, United States

Site Status

Indiana Oncology and Hematology Consultants

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Site Status

Hematology and Oncology Specialists, LLC

New Orleans, Louisiana, United States

Site Status

Louisiana State University Health Sciences Center and VA

Shreveport, Louisiana, United States

Site Status

Maine Center for Cancer Medicine & Blood Disorders

Scarborough, Maine, United States

Site Status

Kansas City Oncology and Hematology Group

Kansas City, Missouri, United States

Site Status

Benefis Healthcare

Great Falls, Montana, United States

Site Status

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Northern New Jersey Cancer Associates

Hackensack, New Jersey, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Advanced Oncology Associates

New Rochelle, New York, United States

Site Status

Weill Medical College of Cornell University/New York Presbyterian Hospital

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology

Greenville, North Carolina, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Columbus, Ohio, United States

Site Status

Hematology Oncology Consultants, Inc.

Columbus, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

Germantown Cancer Foundation

Germantown, Tennessee, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IL2NHL03

Identifier Type: -

Identifier Source: org_study_id

NCT00066534

Identifier Type: -

Identifier Source: nct_alias