Clinical trial NCT00045877: Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: Low-Grade or Follicular Non-Hodgkin's Lymphoma
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2002-09-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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%.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center
state: California
city: Glendale
country: United States
facility: Pacific Shores Medical Group
state: California
city: Glendora
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Greenbrae
country: United States
facility: California Cancer Care Inc.
state: California
city: Huntington Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Lompoc
country: United States
facility: Santa Barbara Hematology Oncology Medical Group
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Alamitos
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLS Medical Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Mission Hills
country: United States
facility: North Valley Hematology-Oncology Medical Group
state: California
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Pasadena
country: United States
facility: UCLA Medical Group/Pasadena Oncology
state: California
city: Pasadena
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Poway
country: United States
facility: Southwest Cancer Care
state: California
city: Rancho Cucamonga
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Meidcal Group, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Foundation Medical Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Santa Barbara Hematology Oncology Medical Group
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Solvang
country: United States
facility: Santa Barbara Hematology Oncology Medical Group
state: California
city: Torrance
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Valencia
country: United States
facility: UCLA/Santa Clarita Valley Cancer Center
state: California
city: Ventura
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Vista
country: United States
facility: San Diego Cancer Center Medical Group
state: California
city: West Covina
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Norwalk
country: United States
facility: Whittingham Cancer Center
state: Connecticut
city: Miami
country: United States
facility: Division of Hematology/Oncology, University of Miami, School of Medicine
state: Florida
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists,S.C.
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Oncology and Hematology Consultants
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: New Orleans
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center and VA
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine & Blood Disorders
state: Maine
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Great Falls
country: United States
facility: Benefis Healthcare
state: Montana
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Northern New Jersey Cancer Associates
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New Rochelle
country: United States
facility: Advanced Oncology Associates
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University/New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Greenville
country: United States
facility: East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Germantown
country: United States
facility: Germantown Cancer Foundation
state: Tennessee
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
Study officials:
References: