UAB 9846 PHASE I TRIAL OF 131I-HUCC49DCH2 FOR COLON CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives of this study in patients with metastatic or unresectable colon or rectal cancer, are to: (1) determine the maximum tolerated dose (MTD) of intravenous (IV) 131I-HuCC49ΔCH2 (recombinant humanized murine CC49 antibody with a deleted CH2 region); (2) determine the toxicities, the plasma pharmacokinetics, whole body biodistribution and conjugate stability of IV 131I-HuCC49ΔCH2; (3) determine the ability of 131I-HuCC49ΔCH2 to localize to tumor sites (dosimetry estimates to tumor, normal organs and whole body will be determined); and (4) characterize the human immune response against 131I-HuCC49ΔCH2 and determine the feasibility of administering two treatment infusions. Perspective participants will have preliminary tests conducted to determine their eligibility for enrollement in the study. The first group of patients will receive 10 mCi 131I-HuCC49ΔCH2 as a diagnostic/dosimetry study. Once dosimetry information from this group is obtained, the therapeutic starting dose level will be established for subsequent groups. On the day of antibody infusion, the patient will be closely observed for allegic reaction. To determine whether the antibody has bound to cancer cells, several specialized scans will be conduted during the first week after treatment; blood samples will be collected to determine the effects on blood cells and organ function as well the antibody to determine the antibody levels in the system. Patients will be followed at 6-month intervals for up to two years.