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Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033423 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I, Multicenter, Open Label, Dose Escalation Of 90Y-Zevalin Radioimmunotherapy Using A Modified Treatment Regimen For Relapsed Or Refractory CD20+ B-Cell (Follicular/Transformed) Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan.
Patients receive rituximab IV once weekly on weeks 1-4. After 4 doses of rituximab, patients without bone marrow involvement and cellularity greater than 50% expected receive rituximab IV once weekly on weeks 6 and 7 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes with the final dose of rituximab (day 43).
Cohorts of 5-6 patients receive escalating dose of yttrium Y 90 ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 5 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 6 and 12 weeks, every 2-3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No impaired bone marrow reserve defined as at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford Comprehensive Cancer Center - Stanford | |
Stanford, California, United States, 94305 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Andres Forero-Torres, MD, CSU | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000069282, UAB-0127, UAB-F010806018, NCI-G02-2053 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033423 |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent marginal zone lymphoma |
recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Chronic lymphocytic leukemia Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Recurrence Antibodies, Monoclonal Lymphoma, B-Cell |
Lymphatic Diseases Antibodies Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |