A Phase I Study of Actinium-225-Labeled HuM195 Antibody in Patients with Advanced Myeloid Malignancies

Protocol
02-017
Full Title
Phase I Trial of Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients with Advanced Myeloid Malignancies
Phase
I
Purpose

HuM195 is an antibody that attaches to leukemia cells but not normal cells. It can identify leukemia cells as foreign and kill small amounts of disease. Attaching a radioactive element to HuM195 may make it more effective for killing leukemia cells because the antibody delivers the radiation directly to the leukemia cells, where the radiation kills them.

In this study, investigators are seeking to determine the optimal dose of HuM195 labeled with a radioactive element called actinium-225 that can be used in patients with advanced acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or myelodysplastic syndromes (MDS) that has not responded to treatment, has returned despite treatment, or has been difficult to treat from the beginning.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of AML, CML, or MDS that has not responded to treatment, has returned despite treatment, or has been difficult to treat from the beginning.
  • At least 3 weeks must have passed since the last dose of chemotherapy and 6 weeks since completing any radiation therapy and entry into the study.
  • Patients with compatible bone marrow donors and those who are eligible for other effective forms of therapy may not participate in this study.

For more information about this study and to inquire about eligibility, please contact Dr. Dan Douer at 212-639-2471 or Dr. Steven Larson at 212-639-7373.

Disease(s)
Hematology: Myelodysplastic Syndrome
Leukemia
Leukemia: Acute Myelogenous Leukemia
Leukemia: Chronic Myelocytic Leukemia
Leukemia: Myelodysplastic Syndrome
Locations