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

Patient Consent: Arm 1 - Standard-Dose Consolidation

The vaccine will be made from your AML cells which will be killed, frozen, and stored away when you start the study. When you go into remission, researchers will take your normal blood cells and culture them in the laboratory until they become "dendritic cells." Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture. This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 tablespoon) will be drawn to make sure you do not have an infection with HIV/AIDS. If you do, you will not be eligible for this study.

If you are found to be eligible to take part in this study, AML cells will be collected from your blood through a vein in your arm. A blood separator device called an apheresis machine will be used. Each apheresis procedure takes about 3-5 hours. It is similar to donating platelets to a blood bank. During the procedure the blood with tumor cells will be removed and then returned through a second line in the other arm. You may have bone marrow aspirations instead with general anesthesia, usually lasting up to 3 hours. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.

After the AML cells are collected, you will start receiving your induction and consolidation chemotherapy treatment. This treatment is standard of care and is not directly related to your participation in this study. After your first cycle of consolidation treatment, a bone marrow biopsy will be done to find out if you are in complete remission. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. If you are in complete remission then you will have your normal blood stem cells collected, which will be used to make the vaccine. All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells. Beginning 5 days before the first collection, you will receive daily injections under the skin of granulocyte colony stimulating factor (G-CSF). These are given to increase the number of normal stem cells available for collection. On Days 5 and 6 of G-CSF treatment, your normal stem cells will be collected. They will be taken to the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.