Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
Sponsor
Chiron Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00045877
Collaborator
(none)
65
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Primary Purpose:
Treatment
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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%.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 2 | Comprehensive Blood and Cancer Center | Bakersfield | California | United States | 93309 |
| 3 | California Oncology of the Central Valley | Fresno | California | United States | 93710 |
| 4 | Virginia K. Crosson Cancer Center | Fullerton | California | United States | 92835 |
| 5 | Pacific Shores Medical Group | Glendale | California | United States | 91204 |
| 6 | Wilshire Oncology Medical Group | Glendora | California | United States | 91741 |
| 7 | California Cancer Care Inc. | Greenbrae | California | United States | 94904 |
| 8 | Pacific Shores Medical Group | Huntington Beach | California | United States | 92648 |
| 9 | Santa Barbara Hematology Oncology Medical Group | Lompoc | California | United States | 93438 |
| 10 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
| 11 | Pacific Shores Medical Group | Los Alamitos | California | United States | 90720 |
| 12 | UCLS Medical Center | Los Angeles | California | United States | 90095 |
| 13 | Facey Medical Foundation | Mission Hills | California | United States | 91345 |
| 14 | North Valley Hematology-Oncology Medical Group | Mission Hills | California | United States | 91345 |
| 15 | Hoag Cancer Center | Newport Beach | California | United States | 92658 |
| 16 | North Valley Hematology/Oncology Medical Group | Northridge | California | United States | 91328 |
| 17 | Ventura County Hematology-Oncology Specialists | Oxnard | California | United States | 93030 |
| 18 | UCLA Medical Group/Pasadena Oncology | Pasadena | California | United States | 91105 |
| 19 | Wilshire Oncology Medical Group | Pasadena | California | United States | 91105 |
| 20 | Wilshire Oncology Medical Group | Pomona | California | United States | 91767 |
| 21 | Southwest Cancer Care | Poway | California | United States | 92064 |
| 22 | Wilshire Oncology Medical Group | Rancho Cucamonga | California | United States | 91730 |
| 23 | Cancer Care Associates Meidcal Group, Inc. | Redondo Beach | California | United States | 90277 |
| 24 | UC Davis Cancer Center | Sacramento | California | United States | 95817 |
| 25 | Sansum Santa Barbara Foundation Medical Clinic | Santa Barbara | California | United States | 93105 |
| 26 | Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | United States | 93105 |
| 27 | Santa Barbara Hematology Oncology Medical Group | Santa Maria | California | United States | 93454 |
| 28 | John Wayne Cancer Institute | Santa Monica | California | United States | 90404 |
| 29 | Santa Barbara Hematology Oncology Medical Group | Solvang | California | United States | 93463 |
| 30 | Cancer Care Associates Medical Group, Inc. | Torrance | California | United States | 90505 |
| 31 | UCLA/Santa Clarita Valley Cancer Center | Valencia | California | United States | 91355 |
| 32 | Ventura County Hematology-Oncology Specialists | Ventura | California | United States | 93003 |
| 33 | San Diego Cancer Center Medical Group | Vista | California | United States | 92083 |
| 34 | Wilshire Oncology Medical Group | West Covina | California | United States | 91790 |
| 35 | Whittingham Cancer Center | Norwalk | Connecticut | United States | 06856 |
| 36 | Division of Hematology/Oncology, University of Miami, School of Medicine | Miami | Florida | United States | 33136 |
| 37 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 38 | Northwestern University Medical School | Chicago | Illinois | United States | 60611 |
| 39 | Oncology Specialists,S.C. | Park Ridge | Illinois | United States | 60068 |
| 40 | Cancer Care Center | Bloomington | Indiana | United States | 47403 |
| 41 | Indiana Oncology and Hematology Consultants | Indianapolis | Indiana | United States | 46202 |
| 42 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 43 | Consultants in Blood Disorders and Cancer | Louisville | Kentucky | United States | 40207 |
| 44 | Hematology and Oncology Specialists, LLC | New Orleans | Louisiana | United States | 70115 |
| 45 | Louisiana State University Health Sciences Center and VA | Shreveport | Louisiana | United States | 71130 |
| 46 | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine | United States | 04074 |
| 47 | Kansas City Oncology and Hematology Group | Kansas City | Missouri | United States | 64111 |
| 48 | Benefis Healthcare | Great Falls | Montana | United States | 59405 |
| 49 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89052 |
| 50 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89109 |
| 51 | Northern New Jersey Cancer Associates | Hackensack | New Jersey | United States | 07601 |
| 52 | Erie County Medical Center | Buffalo | New York | United States | 14215 |
| 53 | Advanced Oncology Associates | New Rochelle | New York | United States | 10801 |
| 54 | Weill Medical College of Cornell University/New York Presbyterian Hospital | New York | New York | United States | 10021 |
| 55 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 56 | East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology | Greenville | North Carolina | United States | 27858-4354 |
| 57 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 58 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 59 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute | Columbus | Ohio | United States | 43210 |
| 60 | Hematology Oncology Consultants, Inc. | Columbus | Ohio | United States | 43235 |
| 61 | Oregon Health & Science University | Portland | Oregon | United States | 97201 |
| 62 | Cancer Centers of the Carolinas | Greenville | South Carolina | United States | 29605 |
| 63 | Germantown Cancer Foundation | Germantown | Tennessee | United States | 38138 |
| 64 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 65 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
Sponsors and Collaborators
- Chiron Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00045877
Other Study ID Numbers:
- IL2NHL03
- NCT00066534
First Posted:
Sep 16, 2002
Last Update Posted:
Feb 6, 2006
Last Verified:
Feb 1, 2006
Keywords provided by ,
,
Additional relevant MeSH terms: