Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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 more than 30% of the tumor cells have an intensity of 2+ or greater
Patients must have an advanced disease for which no standard or effective treatment is available. Patients who refuse a standard but non-curative treatment is available may also be considered
Karnofsky performance status >= 60% and an estimated survival of at least 3 months
Disqualifiers
Patients should not have any uncontrolled illness including ongoing or uncontrolled active infection
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Pregnant women are excluded from this study because Ac225-DOTA-M5A are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ac225-DOTA-M5A, breastfeeding should be discontinued if the mother is treated with Ac225-DOTA-M5A
Patients with recurrent or progressive brain or leptomeningeal involvement with cancer. Patients that have had previous therapies for brain metastasis or leptomeningeal disease with demonstrated response or stable disease at least four weeks after therapy will be eligible for the trial
Trial design
Treatments tested in this trial
- Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A
- Biospecimen Collection
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov