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| Sponsors and Collaborators: |
University of Alabama at Birmingham National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033423 |
Purpose
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 |
|---|---|---|
|
Lymphoma |
Biological: rituximab Radiation: 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.
Eligibility| 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:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 | University of Alabama at Birmingham |
More Information
| Study ID Numbers: | CDR0000069282, UAB-0127, UAB-F010806018, NCI-G02-2053 |
| Study First Received: | April 9, 2002 |
| Last Updated: | May 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033423 History of Changes |
| 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 |
|
Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Recurrence Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse |
Lymphatic Diseases Antibodies Chronic Lymphocytic Leukemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
|
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Pharmacologic Actions |