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Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines

This study has been terminated.
(Terminated early due to slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00514189
First received: August 8, 2007
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

Primary Objectives:

  1. 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.
  2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
  3. To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.

Secondary Objectives:

  1. To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
  2. 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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Time to Adverse Event (AE) [ Time Frame: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other Name: DCs

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
  3. History of systemic autoimmune disease
  4. Positive antibody to human immunodeficiency virus
  5. Patients with Acute promyelocytic Leukemia are not eligible for this study.
  6. Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17)
  7. 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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Chitra M. Hosing, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00514189     History of Changes
Other Study ID Numbers: 2005-0379
Study First Received: August 8, 2007
Last Updated: July 27, 2012
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

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

ClinicalTrials.gov processed this record on May 16, 2013