Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082836
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2004-05-14
Brief Title:
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
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:
RATIONALE Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells
PURPOSE This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma
PURPOSE This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan for imaging in patients with recurrent primary CNS lymphoma
Secondary
Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients
Tertiary
Determine the radiographic response in patients treated with this drug
OUTLINE Patients receive rituximab IV on day 1 Within 4 hours after rituximab administration patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes Patients then undergo whole body imaging Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7
Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan for imaging in patients with recurrent primary CNS lymphoma
Secondary
Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients
Tertiary
Determine the radiographic response in patients treated with this drug
OUTLINE Patients receive rituximab IV on day 1 Within 4 hours after rituximab administration patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes Patients then undergo whole body imaging Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7
Patients are followed monthly for 3 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04009 | None | None | None |