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Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.

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 Intermediate and High-Grade Non-Hodgkin's Lymphoma

Eligibility Criteria

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

Inclusion: Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens. Exclusion: Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment Clinically significant pulmonary dysfunction. Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment). Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism. History of autoimmune disease. History of positive serology for human immunodeficiency virus (HIV).

Sites / Locations

  • ACRC/Arizona Clinical Research Center, Inc.
  • Hoag Cancer Center
  • UC Davis Cancer Center
  • John Wayne Cancer Institute
  • Stanford University Medical Center
  • California Cancer Medical Center
  • Georgetown University Medical Center, Lombardi Cancer Center
  • Washington Cancer Institute
  • Division of Hematology/Oncology, University of Miami School of Medicine
  • Northwestern University, Feinberg School of Medicine
  • Rush Cancer Institute
  • Oncology Specialists, S.C.
  • Cancer Care Center
  • Consultants in Blood Disorders and Cancer
  • Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
  • Kansas City Oncology and Hematology Group
  • Arch Medical Group, LLC
  • Dartmouth-Hitchcock-Medical Center
  • Our Lady of Mercy Medical Center, Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • East Carolina University School of Medicine/ Division of Hematology/Oncology
  • Roger Maris Health System
  • Gabrail Cancer Center
  • Oncology Hematology Care Inc.
  • The Cleveland Clinic Foundation
  • Hematology /Oncology Consultants Inc.
  • Oregon Heath and Science University
  • University of Pennsylvania
  • Cancer Centers of the Carolinas
  • Germantown Cancer Center
  • Vanderbilt University Medical Center
  • Cancer Specialists of South Texas, P.A.
  • 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
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1. Study Identification

Unique Protocol Identification Number
NCT00045864
Brief Title
Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.
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 intermediate-and high- grade Non-Hodgkin's lymphoma.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

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
Inclusion: Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens. Exclusion: Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment Clinically significant pulmonary dysfunction. Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment). Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism. History of autoimmune disease. History of positive serology for human immunodeficiency virus (HIV).
Facility Information:
Facility Name
ACRC/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
UC Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5151
Country
United States
Facility Name
California Cancer Medical Center
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Georgetown University Medical Center, Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Division of Hematology/Oncology, University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
333136
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Cancer Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
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
Arch Medical Group, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth-Hitchcock-Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Our Lady of Mercy Medical Center, Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
East Carolina University School of Medicine/ Division of Hematology/Oncology
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Roger Maris Health System
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oncology Hematology Care Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hematology /Oncology Consultants Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Oregon Heath and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Germantown Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cancer Specialists of South Texas, P.A.
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

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Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.

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