search
Back to results

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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant Human Interleukin-2 and Rituximab
Sponsored by
Chiron Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Low-Grade or Follicular Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Comprehensive Blood and Cancer Center
  • California Oncology of the Central Valley
  • Virginia K. Crosson Cancer Center
  • Pacific Shores Medical Group
  • Wilshire Oncology Medical Group
  • California Cancer Care Inc.
  • Pacific Shores Medical Group
  • Santa Barbara Hematology Oncology Medical Group
  • Pacific Shores Medical Group
  • Pacific Shores Medical Group
  • UCLS Medical Center
  • Facey Medical Foundation
  • North Valley Hematology-Oncology Medical Group
  • Hoag Cancer Center
  • North Valley Hematology/Oncology Medical Group
  • Ventura County Hematology-Oncology Specialists
  • UCLA Medical Group/Pasadena Oncology
  • Wilshire Oncology Medical Group
  • Wilshire Oncology Medical Group
  • Southwest Cancer Care
  • Wilshire Oncology Medical Group
  • Cancer Care Associates Meidcal Group, Inc.
  • UC Davis Cancer Center
  • Sansum Santa Barbara Foundation Medical Clinic
  • Santa Barbara Hematology Oncology Medical Group, Inc.
  • Santa Barbara Hematology Oncology Medical Group
  • John Wayne Cancer Institute
  • Santa Barbara Hematology Oncology Medical Group
  • Cancer Care Associates Medical Group, Inc.
  • UCLA/Santa Clarita Valley Cancer Center
  • Ventura County Hematology-Oncology Specialists
  • San Diego Cancer Center Medical Group
  • Wilshire Oncology Medical Group
  • Whittingham Cancer Center
  • Division of Hematology/Oncology, University of Miami, School of Medicine
  • Cancer Research Center of Hawaii
  • Northwestern University Medical School
  • Oncology Specialists,S.C.
  • Cancer Care Center
  • Indiana Oncology and Hematology Consultants
  • University of Iowa Hospitals and Clinics
  • Consultants in Blood Disorders and Cancer
  • Hematology and Oncology Specialists, LLC
  • Louisiana State University Health Sciences Center and VA
  • Maine Center for Cancer Medicine & Blood Disorders
  • Kansas City Oncology and Hematology Group
  • Benefis Healthcare
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Centers of Nevada
  • Northern New Jersey Cancer Associates
  • Erie County Medical Center
  • Advanced Oncology Associates
  • Weill Medical College of Cornell University/New York Presbyterian Hospital
  • Mount Sinai School of Medicine
  • East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
  • Gabrail Cancer Center
  • The Cleveland Clinic Foundation
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
  • Hematology Oncology Consultants, Inc.
  • Oregon Health & Science University
  • Cancer Centers of the Carolinas
  • Germantown Cancer Foundation
  • Fletcher Allen Health Care
  • Virginia Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2002
Last Updated
February 2, 2006
Sponsor
Chiron Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00045877
Brief Title
Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chiron Corporation

4. Oversight

5. 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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Low-Grade or Follicular Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interleukin-2 and Rituximab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%.
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Virginia K. Crosson Cancer Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pacific Shores Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
California Cancer Care Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Pacific Shores Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group
City
Lompoc
State/Province
California
ZIP/Postal Code
93438
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pacific Shores Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
UCLS Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
North Valley Hematology-Oncology Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
UCLA Medical Group/Pasadena Oncology
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Cancer Care Associates Meidcal Group, Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UC Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sansum Santa Barbara Foundation Medical Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group
City
Solvang
State/Province
California
ZIP/Postal Code
93463
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
UCLA/Santa Clarita Valley Cancer Center
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
San Diego Cancer Center Medical Group
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Division of Hematology/Oncology, University of Miami, School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Oncology Specialists,S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Cancer Care Center
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Indiana Oncology and Hematology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisiana State University Health Sciences Center and VA
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Maine Center for Cancer Medicine & Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Northern New Jersey Cancer Associates
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Advanced Oncology Associates
City
New Rochelle
State/Province
New York
ZIP/Postal Code
10801
Country
United States
Facility Name
Weill Medical College of Cornell University/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hematology Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Germantown Cancer Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs