Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060294
Status:
TERMINATED
Last Update Posted:
2013-01-08
First Post:
2003-05-06
Brief Title:
Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of Zevalin 90Y-Ibritumomab Tiuxetan in Waldenstroms Macroglobulinemia Lymphoplasmacytic Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Waldenstroms macroglobulinemia
PURPOSE Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstroms 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
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstroms 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0202063 | None | None | None |
| IDEC-UCLA-0202063 | None | None | None |