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

Institut Paoli-Calmettes10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Leukemia

Interventions

therapeutic autologous dendritic cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, France

Outcomes

Primary Outcomes

Adverse events at 6 months

Data from ClinicalTrials.gov

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