Trial Information

Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell
vaccine in patients with acute myeloid leukemia.

- Determine the toxicity of this vaccine in these patients.

Secondary

- Determine whether cellular immunity can be induced by this vaccine in these patients.

OUTLINE: This is a dose-escalation study.

At the time of diagnosis, patients undergo tumor cell harvest. Patients also undergo bone
marrow aspiration to collect mononuclear cells to obtain dendritic cells (DC). If
insufficient DCs are obtained, patients undergo leukapheresis to obtain a sufficient number
of peripheral blood mononuclear cells (PBMC). The PBMC are treated in the laboratory with
sargramostim (GM-CSF) and interleukin-4 for 5-7 days to produce DC. Leukemic blasts are
fused to DC to generate the dendritic/leukemic fusion cell vaccine.

Patients then undergo standard induction chemotherapy to obtain a remission, followed by
standard consolidation chemotherapy.

After completing consolidation chemotherapy, patients receive autologous dendritic and
leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion
cell vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.