Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
LeukemiaMyelodysplastic Syndrome
Interventions
BIOLOGICAL

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.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Actinium Pharmaceuticals

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER