Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199862
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2005-09-13
Brief Title:
Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of Radioimmunodetection of 124-Iodine-labeled Humanized A33 Antibody 124I-huA33 in Patients With Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to determine whether our drug 124I-huA33 can safely detect colorectal cancer
Detailed Description:
This is an open-label pilot study of a single 4mCi-10mCi10mg IV dose of 124I-huA33 in patients with colorectal cancer Patients will be studied with 124I-huA33 positron-emission tomography PET and in the subset of patients scheduled for surgery based on clinical indications ex vivo quantitation of tumor uptake will also be performed Patients will receive a single intravenous or intraarterial infusion of 4 mCi-10mCi 10mg 124I-huA33 in 5-30ml of 5 human serum albumin HSA over 5-10 minutes Patient will either receive the 124I-huA33 intravenously IV or intraarterially IA to determine if there is an advantage of the IV vs the IA route Following injection with 124I-huA33 on study days 2 3 and or 4 patients will have the option to receive up to 2g1kg of Immune Globulin IVIG
Blood samples will be obtained for pharmacokinetic analysis at 5 15 60 and 120 minutes after completion of IV or IA infusion on day 2 3 and or 4 and before and after the PET scan on the day of surgery or last imaging day day 8 3 Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery
In those patients undergoing surgery surgery or biopsy will be scheduled to occur day 8 3 days days after administration of 124I-huA33 Biopsy sites may include tumor tumor bed regional nodes portal suprapancreatic celiac nodes and the retroperitoneum Tumor and normal tissue obtained at surgery or biopsy and serum will be measured for estimation of percent-injected dose per gram of tumor normal liver and serum Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting
Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks
Toxicity assessments will be made throughout the study period
Blood samples will be obtained for pharmacokinetic analysis at 5 15 60 and 120 minutes after completion of IV or IA infusion on day 2 3 and or 4 and before and after the PET scan on the day of surgery or last imaging day day 8 3 Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery
In those patients undergoing surgery surgery or biopsy will be scheduled to occur day 8 3 days days after administration of 124I-huA33 Biopsy sites may include tumor tumor bed regional nodes portal suprapancreatic celiac nodes and the retroperitoneum Tumor and normal tissue obtained at surgery or biopsy and serum will be measured for estimation of percent-injected dose per gram of tumor normal liver and serum Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting
Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks
Toxicity assessments will be made throughout the study period
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