Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003360
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma
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 can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with advanced colorectal cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with advanced colorectal cancer
Detailed Description:
OBJECTIVES I Define the toxicity and determine the maximum tolerated dose of iodine I 131 humanized monoclonal antibody A33 131I-huAb A33 in patients with advanced colorectal cancer II Describe pharmacokinetics and biodistribution of 131I-huAb A33 by external imaging in these patients III Determine the effect of human antihuman antibody response on pharmacokinetics and targeting of 131I-huAb A33 in this patient population IV Determine whether the dose planning methodology used here can adequately and safely be applied to routine radioimmunotherapy planning
OUTLINE Patients receive iodine I 131 humanized monoclonal antibody A33 131I-huAb A33 by IV infusion over 20 minutes every 6-8 days for up to 8 weeks depending on dosage Patients receive a minimum of 6 weeks of treatments In the absence of disease progression or unacceptable toxicity patients are retreated no sooner than 6 weeks after the previous course Cohorts of 3-6 patients receive escalating doses of 131I-huAb A33 to determine the maximum tolerated dose MTD The MTD is defined as the highest dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed for 6 weeks after the last treatment
PROJECTED ACCRUAL There will be 3-24 patients accrued into this study over 16 months
OUTLINE Patients receive iodine I 131 humanized monoclonal antibody A33 131I-huAb A33 by IV infusion over 20 minutes every 6-8 days for up to 8 weeks depending on dosage Patients receive a minimum of 6 weeks of treatments In the absence of disease progression or unacceptable toxicity patients are retreated no sooner than 6 weeks after the previous course Cohorts of 3-6 patients receive escalating doses of 131I-huAb A33 to determine the maximum tolerated dose MTD The MTD is defined as the highest dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed for 6 weeks after the last treatment
PROJECTED ACCRUAL There will be 3-24 patients accrued into this study over 16 months
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-H98-0017 | None | None | None |
| MSKCC-98011 | None | None | None |