Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00514189

Purpose

Primary Objectives:

To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy.
To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.

Secondary Objectives:

To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.

Condition	Intervention	Phase
Leukemia	Biological: Autologous Dendritic Cells	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if it possible to make a vaccine from your own AML cells that could activate your immune system against your leukemia. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The safety and effectiveness of the vaccine will also be studied. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Autologous Dendritic Cells	Biological: Autologous Dendritic Cells The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Untreated AML except patients with inv (16), t(8;21), or t (15;17) cytogenetics or AML in first relapse.
Patients must have >/= 2,000 circulating blasts/ul peripheral blood or >/= 50% blasts in bone marrow biopsy
Performance Status 0-2

Exclusion Criteria:

Medical, social or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
History of systemic autoimmune disease
Positive antibody to human immunodeficiency virus
Patients with Acute promyelocytic Leukemia are not eligible for this study.
Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17)
Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514189

Contacts

Contact: Chitra M. Hosing, MD

713-745-2161

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Chitra M. Hosing, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Chitra M. Hosing, MD

U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Chitra M. Hosing, MD/Associate Professor )
Study ID Numbers:	2005-0379
Study First Received:	August 8, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00514189
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Acute Myelogenous Leukemia
Leukemia
Autologous Dendritic Cells

Vaccine
AML
mRNA

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009