Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033423
Status:
TERMINATED
Last Update Posted:
2013-12-13
First Post:
2002-04-09
Brief Title:
Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
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 FollicularTransformed Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-12
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:
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-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade follicular or transformed CD20-positive B-cell non-Hodgkins lymphoma NHL
Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen
Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen
Determine the antitumor response in patients treated with this regimen
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
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade follicular or transformed CD20-positive B-cell non-Hodgkins lymphoma NHL
Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen
Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen
Determine the antitumor response in patients treated with this regimen
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
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 |
|---|---|---|---|
| NCI-G02-2053 | None | None | None |
| UAB-0127 | None | None | None |
| UAB-F010806018 | None | None | None |