Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00060294|
Recruitment Status : Terminated (no accrual)
First Posted : May 7, 2003
Last Update Posted : January 8, 2013
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 or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan||Phase 1|
- Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia.
- Determine, preliminarily, the response of patients treated with this drug.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)|
|Study Start Date :||April 2003|
|Primary Completion Date :||June 2004|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060294
|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|