Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the WT-1 vaccine causes an immune response and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system can recognize as abnormal.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Innovive Pharmaceuticals
• Treatments: Sargramostim; Vaccines

Criteria

Inclusion Criteria:

• Cytologic or histologic diagnosis of acute myelogenous leukemia or myelodysplastic syndrome confirmed at Moffitt Cancer Center.

• Patients with acute myelogenous leukemia will have completed induction chemotherapy, achieved first complete remission (CR) 1 or 2, and will have completed any planned postremission therapy (at discretion of treating physician),with no plan for allogenic or autologous transplant.

• Patients with myelodysplastic syndrome who according to the International Prognostic Scoring System (IPSS) are category Int-2 or greater, with disease that relapsed, progressed, or not responded to at least 1 prior course of approved therapy for MDS (i.e. hypomethylating agent or lenalidomide).

• Patients with AML/MDS must have documented WT-1 + disease. For purposes of this study, this may be either the demonstration of WT-1 protein on a pretreatment bone marrow biopsy or detectable disease with RQ-PCR. For patients in whom a bone marrow aspirate is not available or possible (e.g. "dry tap"), a peripheral blood sample may be used for WT-1 screening. In such cases, 10 cc of peripheral blood will be collected in a heparinized tube.

• At least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.

• Karnofsky performance status ≥ 70%

• Hematologic parameters:

• Absolute neutrophil count ≥ 1000/mcL (except for MDS, for which the parameter is ≥ 500/mcL)

• Platelets > 50 K/mcL (except for MDS for which the parameter is > 25 K/mcL and not transfusion dependent)

• Biochemical parameters:

• Total bilirubin ≤ 2.0 mg/dl

• Aspartic transaminase (AST) and Alanine transaminase (ALT) ≤ 2.5 x upper limits of normal

• Creatinine ≤ 2.0 mg/dl

Exclusion Criteria:

• Pregnant or lactating women

• Patients with leptomeningeal disease

• Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments

• Patients with serious unstable medical illness

• Patients taking systemic corticosteroids

• Patients with central nervous system (CNS) involvement with cancer/leukemia