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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: | NCT00060294 |
RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma) |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 3-24 patients 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:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy
Clinical indication for initiation of treatment, including 1 or more of the following characteristics:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000301591, UCLA-0202063, IDEC-UCLA-0202063 |
Study First Received: | May 6, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00060294 History of Changes |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia |
Immunoproliferative Disorders Immunologic Factors Rituximab Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Waldenstrom Macroglobulinemia Hemorrhagic Disorders Lymphoproliferative Disorders Lymphoma Immunoglobulins Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Hematologic Diseases Blood Protein Disorders Physiological Effects of Drugs Vascular Diseases Paraproteinemias Hemostatic Disorders |
Pharmacologic Actions Antibodies, Monoclonal Lymphatic Diseases Waldenstrom Macroglobulinemia Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |