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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963521
First received: August 20, 2009
Last updated: May 12, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia
 Biological: therapeutic autologous dendritic cells
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Adverse events at 6 months [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963521

Locations
France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Investigator: Christian Chabannon, MD, PhD Institut Paoli-Calmettes
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00963521     History of Changes
Other Study ID Numbers: CDR0000626786, IPC-2006-011, INCA-RECF-0628, EUDRACT-2006-007093-29, IPC-LADC
Study First Received: August 20, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloid leukemia in remission
 adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013