Vaccine Therapy in Treating Patients With Acute Myeloid 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.

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Key information

Conditions

Leukemia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Marseille, 13273, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic autologous dendritic cells

Biological

Primary outcomes

Adverse events at 6 months

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
First posted: Aug 21, 2009
Registry last updated: May 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed