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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00056043 |
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one monoclonal antibody may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining two different monoclonal antibodies in treating patients who have relapsed or refractory follicular non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: galiximab Drug: rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial Of IDEC-114 (Anti-CD80 Monoclonal Antibody) In Combination With Rituximab For Patients With Relapsed Or Refractory, Follicular Lymphoma |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study of IDEC-114 monoclonal antibody (IDEC-114).
Cohorts of 3-6 patients receive escalating doses of IDEC-114 until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 39-48 patients (9-18 patients for phase I and 30 patients for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed follicular non-Hodgkin's lymphoma (NHL)
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 |
Principal Investigator: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000271926, UCLA-0207122, IDEC-114-21, UNMC-04703 |
Study First Received: | March 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00056043 |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
Immunoproliferative Disorders Rituximab Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Recurrence Antibodies, Monoclonal Lymphatic Diseases |
Antibodies Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |