Lymphoma, Non-Hodgkin Clinical Trial
| NCT number | NCT00045877 |
| Other study ID # | IL2NHL03 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| First received | September 12, 2002 |
| Last updated | February 2, 2006 |
| Verified date | February 2006 |
| Source | Chiron Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Cancer Care Center | Bloomington | Indiana |
| United States | Erie County Medical Center | Buffalo | New York |
| United States | Fletcher Allen Health Care | Burlington | Vermont |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Northwestern University Medical School | Chicago | Illinois |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute | Columbus | Ohio |
| United States | Hematology Oncology Consultants, Inc. | Columbus | Ohio |
| United States | California Oncology of the Central Valley | Fresno | California |
| United States | Virginia K. Crosson Cancer Center | Fullerton | California |
| United States | Germantown Cancer Foundation | Germantown | Tennessee |
| United States | Pacific Shores Medical Group | Glendale | California |
| United States | Wilshire Oncology Medical Group | Glendora | California |
| United States | Benefis Healthcare | Great Falls | Montana |
| United States | California Cancer Care Inc. | Greenbrae | California |
| United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
| United States | East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology | Greenville | North Carolina |
| United States | Northern New Jersey Cancer Associates | Hackensack | New Jersey |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
| United States | Pacific Shores Medical Group | Huntington Beach | California |
| United States | Indiana Oncology and Hematology Consultants | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Kansas City Oncology and Hematology Group | Kansas City | Missouri |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Santa Barbara Hematology Oncology Medical Group | Lompoc | California |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Pacific Shores Medical Group | Los Alamitos | California |
| United States | UCLS Medical Center | Los Angeles | California |
| United States | Consultants in Blood Disorders and Cancer | Louisville | Kentucky |
| United States | Division of Hematology/Oncology, University of Miami, School of Medicine | Miami | Florida |
| United States | Facey Medical Foundation | Mission Hills | California |
| United States | North Valley Hematology-Oncology Medical Group | Mission Hills | California |
| United States | Hematology and Oncology Specialists, LLC | New Orleans | Louisiana |
| United States | Advanced Oncology Associates | New Rochelle | New York |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | Weill Medical College of Cornell University/New York Presbyterian Hospital | New York | New York |
| United States | Hoag Cancer Center | Newport Beach | California |
| United States | North Valley Hematology/Oncology Medical Group | Northridge | California |
| United States | Whittingham Cancer Center | Norwalk | Connecticut |
| United States | Ventura County Hematology-Oncology Specialists | Oxnard | California |
| United States | Oncology Specialists,S.C. | Park Ridge | Illinois |
| United States | UCLA Medical Group/Pasadena Oncology | Pasadena | California |
| United States | Wilshire Oncology Medical Group | Pasadena | California |
| United States | Wilshire Oncology Medical Group | Pomona | California |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Southwest Cancer Care | Poway | California |
| United States | Wilshire Oncology Medical Group | Rancho Cucamonga | California |
| United States | Cancer Care Associates Meidcal Group, Inc. | Redondo Beach | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | UC Davis Cancer Center | Sacramento | California |
| United States | Sansum Santa Barbara Foundation Medical Clinic | Santa Barbara | California |
| United States | Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California |
| United States | Santa Barbara Hematology Oncology Medical Group | Santa Maria | California |
| United States | John Wayne Cancer Institute | Santa Monica | California |
| United States | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine |
| United States | Louisiana State University Health Sciences Center and VA | Shreveport | Louisiana |
| United States | Santa Barbara Hematology Oncology Medical Group | Solvang | California |
| United States | Cancer Care Associates Medical Group, Inc. | Torrance | California |
| United States | UCLA/Santa Clarita Valley Cancer Center | Valencia | California |
| United States | Ventura County Hematology-Oncology Specialists | Ventura | California |
| United States | San Diego Cancer Center Medical Group | Vista | California |
| United States | Wilshire Oncology Medical Group | West Covina | California |
| Lead Sponsor | Collaborator |
|---|---|
| Chiron Corporation |
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