Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416312
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2006-12-27
Brief Title:
Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Dose-Response in Radioimmunotherapy of Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-07
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 Radiolabeled monoclonal antibodies such as iodine I 131 tositumomab and yttrium Y 90 ibritumomab tiuxetan can find cancer cells and carry cancer-killing substances to them without harming normal cells This may be an effective treatment for non-Hodgkins lymphoma
PURPOSE This clinical trial is studying the side effects best dose and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkins lymphoma
PURPOSE This clinical trial is studying the side effects best dose and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkins lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan
Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients
Secondary
Assess the difference in the dose-response relationship between dosimetric methodologies in these patients
Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients
OUTLINE Patients are stratified according to planned radioimmunotherapy treatment iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan
Stratum 1 Patients receive dosimetric rituximab IV followed by indium In 111 111In ibritumomab tiuxetan IV over 10 minutes on day 1 Patients undergo positron emission tomography PETCT scans and single-photon emission computed tomography SPECTCT scans between 2-24 48-72 and 90-120 hours after 111In ibritumomab tiuxetan administration Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9
Stratum 2 Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 131I tositumomab IV over 20 minutes on day 0 Patients undergo PETCT scans and SPECTCT scans on days 0 2 3 or 4 and 6 or 7 Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by 131I tositumomab IV over 20 minutes on approximately day 7
In both strata blood is collected at baseline to measure FLT-3 levels All patients also undergo a baseline PETCT scan
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 88 patients will be accrued for this study
Primary
Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkins lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan
Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients
Secondary
Assess the difference in the dose-response relationship between dosimetric methodologies in these patients
Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients
OUTLINE Patients are stratified according to planned radioimmunotherapy treatment iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan
Stratum 1 Patients receive dosimetric rituximab IV followed by indium In 111 111In ibritumomab tiuxetan IV over 10 minutes on day 1 Patients undergo positron emission tomography PETCT scans and single-photon emission computed tomography SPECTCT scans between 2-24 48-72 and 90-120 hours after 111In ibritumomab tiuxetan administration Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9
Stratum 2 Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 131I tositumomab IV over 20 minutes on day 0 Patients undergo PETCT scans and SPECTCT scans on days 0 2 3 or 4 and 6 or 7 Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by 131I tositumomab IV over 20 minutes on approximately day 7
In both strata blood is collected at baseline to measure FLT-3 levels All patients also undergo a baseline PETCT scan
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 88 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 |
|---|---|---|---|
| CDR0000522705 | REGISTRY | None | None |
| R01CA116477-01A1 | NIH | None | None |
| NA_00001712 | OTHER | JHM IRB | httpsreporternihgovquickSearchR01CA116477-01A1 |