Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064246
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2003-07-08
Brief Title:
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant 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
Detailed Description:
OBJECTIVES
I Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 in patients with post-transplant lymphoproliferative disorder
II Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients
III Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
Phase I Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 Patients undergo 2 or 3 if needed imaging scans between days 1-6 In the absence of altered biodistribution patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of IDEC-Y2B8 Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 years
I Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 in patients with post-transplant lymphoproliferative disorder
II Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients
III Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
Phase I Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 Patients undergo 2 or 3 if needed imaging scans between days 1-6 In the absence of altered biodistribution patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of IDEC-Y2B8 Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 years
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 |
|---|---|---|---|
| AMC-037 | None | None | None |
| U01CA070019 | NIH | None | None |
| CDR0000310158 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA070019 |