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Study Summary
No. 2005-0379:.......Leukemia......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:		2005-0379
Study Title:Feasibility Study of Acute Myelogenous Leukemia mRNA plus Lysate Loaded Dendritic Cell Vaccines
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Physician New Patient Referral
Name:Chitra M. HosingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2161
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IReturn
Visit:		Prior to aphereses and each DC vaccine. After the 4th DC vaccination patients
will be followed-up on a yearly basis for overall survival. This follow-up can
be done by a phone call.
Treatment
Agents:		NoneHome Care:none
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		the vaccine portion will be outpatient and require six months
Description/
Intervention:		The goal of this clinical research study is to learn if it possible to make a
vaccine from your own AML cells that could activate your immune system against
your leukemia. Researchers want to give this vaccine to you after your receive
chemotherapy and have no detectable AML left in your bone marrow or blood. The
safety and effectiveness of the vaccine will also be studied.
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Study Objectives / Outcomes
This is a single arm (non-randomized) study to evaluate feasibility and safety of the dendritic cell vaccine in two different patient groups: AML patients at initial diagnosis and those in relapse. Patients who present at initial diagnosis (Arm 1) will receive standard-dose induction and standard-dose consolidation therapy, followed by the vaccine. Patients who present in relapse (Arm 2) will receive standard-dose induction and for consolidation, high-dose therapy and autologous stem cell transplantation followed by the vaccine.

PRIMARY ENDPOINTS
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 ENDPOINTS
    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
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    Study Status Information
    Study Activation / Registration Date:07/26/2007
    IRB Review and Approval Date:10/26/2005
    Study Type:Phase I
    Recruitment Status:Terminated
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) At study enrollment: Acute leukemia with >/= 2,000 circulating blasts/ul peripheral blood or >/= 50% blasts in bone marrow biopsy.

    2) Performance Status 0-2

    3) At Vaccination: AML in complete remission EXCEPT patients with inv (16), t(8;21), or t (15;17) cytogenetics
    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
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    Links
    Registration Number: NCT00514189
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center