Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms
Completed · Not applicable
Conditions studied: Leukemia
In brief
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.
Key facts
- Study ID
- NCT00665002
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 16
- Starts
- 2008-06-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2015-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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