Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.
Drug: Unconjugated IDEC-159
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma|
- To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.
- To evaluate activity; blood, normal organ, and tumor dosimetry; the immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 (sTAG-72) levels.
|Study Start Date:||January 2005|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|Principal Investigator:||Andres Forero, M.D.||Comprehensive Cancer Center, University of Alabama at Birmingham|