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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514189
Recruitment Status : Terminated (Terminated early due to slow accrual.)
First Posted : August 9, 2007
Last Update Posted : July 30, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Biological: Autologous Dendritic Cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
Study Start Date : July 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to Adverse Event (AE) [ Time Frame: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514189

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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)
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Principal Investigator: Chitra M. Hosing, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00514189    
Other Study ID Numbers: 2005-0379
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
Autologous Dendritic Cells
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type