drugset / Trial / NCT00005940

Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission

NCT00005940

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well iodine I 131 monoclonal antibody BC8, busulfan, and cyclophosphamide followed by donor stem cell transplant works in treating patients with acute myeloid leukemia that has decreased or disappeared, but the cancer may still be in the body. Giving chemotherapy drugs, such as busulfan and cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Timeline

Start
1999-10
Primary completion
2006-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject BC8 Monoclonal antibody Intravenous
Subject Busulfan Small molecule 16 mg/kg Oral
Subject Cyclophosphamide Other / unclassified 120 mg/kg Intravenous
Background Cyclosporine Peptide Intravenous
Background Methotrexate Small molecule Intravenous