Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission

Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

OBJECTIVES:

Primary

• Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission.

Secondary

• Evaluate the emergence of an immune response.
• Determine the relapse rate.
• Assess the occurrence of residual disease.

OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.

DISEASE CHARACTERISTICS:

• Diagnosis of acute myelogenous leukemia (AML)

  • Myelomonocytic (M4) or monocytic (M5) subtype
  • In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation

• No (15;17) translocation

• No AML M3

• HLA-A2 positivity

• CD14 ≥ 20% on peripheral blood mononuclear cells

• Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available

• Must not be eligible for HLA-matched allogeneic transplantation

• No progressive disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No contraindication to cytopheresis or chemotherapy
• No HIV or HTLV positivity
• No hepatitis B or C activation
• No prior psychological disease
• Not deprived of liberty and able to give consent
• Must be able to speak and read French
• No other cancer except for basal cell or cervical

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent participation in another clinical study