Clinical Trial · NCT00005940

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

Overview

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.

Sponsor

Fred Hutchinson Cancer Center

Phase

Phase 2

Contacts

Johnnie Orozco (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00005940

Eligibility

Inclusion

Creatinine \< 2.0 mg/dl
DONOR: genotypic or phenotypic HLA-matched family members; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DR beta 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQ beta 1 (DQB1)
Patients must have an expected survival of \> 60 days and must be free of major infection
Patients with AML in first remission
Aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver
Bilirubin \< 1.5 mg/dl which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver

Exclusion

DONOR: donors who are seropositive for HIV
Prior radiation to maximally tolerated levels to any normal organ
Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation
Patients with history of or current leukemic involvement of the central nervous system (CNS)
DONOR: unrelated donors and donors mismatched for 1 or more HLA antigens
Patients who are seropositive for human immunodeficiency virus (HIV)
DONOR: donors who for psychologic, physiologic or medical reasons are unable to undergo filgrastim (G-CSF)- mobilized PBSC collection or marrow harvesting
Circulating antibody against mouse immunoglobulin