A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies
- To establish the maximum tolerated dose of yttrium Y 90 DOTA anti-CEA monoclonal
antibody M5A and describe the toxicities at each dose studied.
- To estimate radiation doses to whole body, normal organs, and tumor through serial
nuclear imaging studies after intravenous infusion of the yttrium Y 90 DOTA anti-CEA
monoclonal antibody M5A.
OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody
M5A (MOAB M5A).
- Biodistribution: Patients receive indium In 111 radiolabeled anti-CEA MOAB M5A IV over
30 minutes. Patients undergo serial nuclear scans, single photon emission computed
tomography (SPECT), and blood and urine sampling over 1 week to estimate absorbed
radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone marrow),
and whole body.
- Treatment: No more than 2 weeks later, patients with adequate biodistribution receive
yttrium Y 90 DOTA anti-CEA MOAB M5A IV over 30 minutes on day 1. Patients then undergo
serial nuclear scans, SPECT, and blood and urine sampling over 1 week to estimate
absorbed radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone
marrow), and whole body. Treatment repeats every 6-10 weeks for up to 2 courses in the
absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected periodically for analysis of total activity by
radiometric high performance liquid chromatography and to acquire data on antibody
metabolism and pharmacokinetics.
After completion of study treatment, patients are followed every 3 months for up to 6
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
10 weeks after the beginning of the last cycle of treatment
Jeffrey Y. Wong, MD
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|