Leukemia Clinical Trial
Official title:
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | February 2015 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Innovive Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events (AEs) | Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed = grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual. | 12 weeks to 6 months | Yes |
Secondary | Participants Whose Samples Demonstrated Immunological Response After Vaccination | Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well. ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release. Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion. Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders). Overall: any form of immune response. |
12 weeks | No |
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