A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)

Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12

This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.

This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.

Inclusion Criteria:

• Patient with AML and >=18 years of age.
• Agrees to participate in the study and signs the informed consent
• Viable cells are available for successful modification
• First or higher complete remission and have high risk features of relapse.
• Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
• Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
• Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
• Agree to use contraception
• Not pregnant
• Able to comply with study procedures

Exclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Known persistent infection
• Known central nervous system (CNS) disease
• Greater than 10% blasts in the bone marrow or circulating blast cells
• Life expectancy < 2 months
• Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
• Patients who are HIV positive.