A Phase I Study of Actinium-225 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced or Metastatic Cancers
City of Hope Medical Center
Summary
This phase I study tests the safety, side effects, and best dose of Ac225-DOTA-M5A in treating patients with CEA positive colorectal cancer that has spread to other places in the body (advanced). Ac225-DOTA-M5A is a humanized monoclonal anti-CEA antibody, linked to a radioactive agent called actinium 225. M5A attaches to CEA positive cancer cells in a targeted way and delivers actinium 225 to kill them.
Description
PRIMARY OBJECTIVE: I. To establish the maximum tolerated dose (MTD) of actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A (225Ac-DOTA-M5A) humanized anti-carcinoembryonic antigen (CEA) antibody when given intravenously and to describe the toxicities at each dose studied. SECONDARY OBJECTIVES: I. To begin to evaluate the clinical activity of the agent in metastatic colorectal cancer. II. To evaluate the organ biodistribution, pharmacokinetics and organ dose estimates of 225Ac-DOTA-M5A. OUTLINE: This is a dose-escalation study. Patients receive Ac225-DOTA-M5A intravenously (IV) over 25…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a histologic diagnosis of a malignancy that expresses CEA. If biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope * Patients must have tumors that produce CEA as documented by either an elevated serum CEA above the institutional limit of normal or by immunohistochemical methods. Positive CEA immunohistochemical staining, for the purposes of this protocol, is graded 0-3 and the percentage of tumor cells positive is estimated. A positive CEA stain is determined if…
Interventions
- DrugActinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A
Given IV
- ProcedureBiospecimen Collection
Correlative studies
Location
- City of Hope Medical CenterDuarte, California