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

Stopped early · Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00514189

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2007-07-01

Expected to finish

2009-12-01

Last updated by the study team

2012-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.