• Primary endpoints are safety, toxicity and immunogenicity of the WT1 vaccine. [ Time Frame: Interim analysis will be performed after enrollment of the first five evaluable patients. ] [ Designated as safety issue: Yes ]
  

• Secondary endpoint is the antitumor effect of the vaccine. [ Time Frame: Interim analysis will be performed after enrollment of the first five evaluable patients. ] [ Designated as safety issue: Yes ]
  

Design:

This will be a pilot trial evaluating the safety and immunogenicity of the WT-1 peptide vaccine in patients with hematologic malignancies. Ten patients with AML or advanced MDS, will be enrolled. Patients will be vaccinated with a preparation of WT-1-derived native and synthetic peptides plus immunologic adjuvant Montanide ISA 51 VG (Seppic Pharmaceuticals, Fairfield, NJ) and Sargramostim (GM-CSF). One dose level will be tested.

Patients will receive 6 injections of the WT-1 vaccine. Doses will be given every 2 weeks. Each vaccine is given at a different location under the skin in the arm or leg. Patients will be monitored for 30 minutes after vaccination. WT-1 vaccine is given with another substance, Montanide, which clumps the WT-1 vaccine and improves the immune response. Patients will also receive an injection of Sargramostim (GM-CSF) 2 days before each vaccination and again on the day of the WT-1 injection at the same spot. Sargramostim (GM-CSF) stimulates the body's white blood cells to boost the immune response. Patients may be taught to do the Sargramostim (GM-CSF) injection themselves in which case patients will be given a log sheet to record the injection time and location.

If not, they will need to come for an additional 24 study visits. To monitor their health while receiving the vaccine, patients will need the following tests and procedures as a part of regular cancer care. History and physical examination every 2 weeks. CBC and comprehensive panel every 2 weeks. Bone marrow aspirate at week 14 for patients with acute myelogenous leukemia or myelodysplastic syndrome. Patients will need these tests and procedures to see whether the vaccine is causing an immune response: A skin test will be performed before patients start the study and again in the 8 and 14 weeks in which a small amount of the vaccine will be placed under the skin. Two days later, the site will be checked to see whether a bump or swelling has formed. Another substance which typically does cause a mild reaction (mumps) will also be placed under the skin to measure whether they have a normal immune reaction. We will take about 7 tablespoons of blood to measure their immune response. About 1 tablespoon of blood will be taken to measure the levels of WT-1 in their blood. Blood samples will be taken prior to receiving the first vaccination and prior to receiving the vaccination at weeks 8 and 14.

If the vaccine causes the patient to have an immune response, and their cancer does not grow, they may continue to receive the WT-1 vaccinations monthly for 6 more months. If this occurs, the patient will have a CT scan or bone marrow test and immunology blood tests two weeks after the 9th and 12th vaccinations.