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Brief Title: Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
Official Title: Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy
Study ID: NCT01384253
Brief Summary: Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases. This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.
Detailed Description:
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Of Alabama at Birmingham, Birmingham, Alabama, United States
UCSD Moores Cancer Center, San Diego, California, United States
Name: Ruby F Meredith, M.D., Ph.D.
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR