23
Participants
Start Date
July 31, 2005
Primary Completion Date
February 28, 2015
Study Completion Date
February 28, 2015
ACTINIUM-225-LABELED HUMANIZED ANTI-CD33 MONOCLONAL ANTIBODY HuM195
A single infusion of 225Ac-HuM195 will be administered at a starting dose of 0.5 μCi/kg. Additionally, 100 mCi of 213Bi-HuM195 have been administered with full dose cytarabine (200 mg/m2 daily for 5 days) without dose-limiting toxicity.Serial sampling of blood, urine, and bone marrow will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antileukemic effects. Three to six patients will be treated at each dose level. Dose escalation will proceed if less than 33% of patients in a cohort experience dose-limiting toxicity.Patients will be followed until completion of therapy as outlined in the study, loss to follow-up, death, or until the day the patient is removed from the study.
Memorial Sloan Kettering Cancer Center, New York
Collaborators (1)
National Cancer Institute (NCI)
NIH
Actinium Pharmaceuticals
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER