Viewing Study NCT00003360



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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
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

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