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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A
DrugGiven IV
Biospecimen Collection
Procedure/SurgeryCorrelative studies
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment (Ac225-DOTA-M5A)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute Common Toxicity Criteria and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), and attribution to study drug. Tables will be created to summarize these toxicities and side effects by dose and by course.
Time frame
Up to 6 months2
Maximum tolerated dose (MTD)
The MTD is defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicities (DLT) attributable to the study drugs, when at least six patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the DLT-level. At least 6 patients will be treated at the MTD.
Time frame
Up to 36 monthsSecondary outcomes
1
Overall survival
From first day of treatment to time of death due to any cause.
Time frame
Assessed up to 6 months2
Progression-free survival
From first day of treatment to the first observation of disease progression or death due to any cause.
Time frame
Assessed up to 6 months3
Time to failure
From first day of treatment to the first observation of disease progression or death due to disease.
Time frame
Assessed up to 6 months4
Best overall response
Evaluated with complete response, partial response, progressive disease or stable disease. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of measurement criteria, but confirmation is not necessary.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov