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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Innovive Pharmaceuticals |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00665002 |
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.
Condition | Intervention |
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Leukemia |
Biological: WT-1 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms |
Estimated Enrollment: | 10 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
WT-1 Analog Peptide Vaccine
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Biological: WT-1
Patients will receive 6 bi-weekly vaccinations over 10 weeks. Immune responses to be evaluated at weeks 6 and 12 via delayed-type hypersensitivity, CD4 T cell proliferation, CD4 and CD8 T cell interferon release, bone marrow cytogenetics including polymerase chain reaction (PCR) to look for molecular evidence of disease. Patients with an immunologic response and not disease progression may continue with up to 6 more vaccinations approximately every month. Such patients will be reevaluated with bone marrows/immunologic studies after the 9th and 12th vaccination. Patients will undergo evaluations for residual disease including immunohistochemistry and/or quantitative polymerase chain reaction (RQ-PCR) for WT-1 expression (selected patients), and multiparameter flow cytometry (AML/ MDS). |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematologic parameters:
Exclusion Criteria:
Contact: Jeffrey Lancet, M.D. | 813-745-3569 | jeffrey.lancet@moffitt.org |
Contact: Michelle Burton | 813-745-3965 | michelle.burton@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Jeffrey Lancet, M.D. 813-745-3569 jeffrey.lancet@moffitt.org | |
Contact: Michelle Burton 813-745-3965 michelle.burton@moffitt.org | |
Principal Investigator: Jeffrey Lancet, M.D. | |
Sub-Investigator: Lodovico Balduci, M.D. | |
Sub-Investigator: Martine Extermann, M.D. | |
Sub-Investigator: Alan List, M.D. | |
Sub-Investigator: Lubomir Sokol, M.D., Ph.D. | |
Sub-Investigator: Eduardo Sotomayor, M.D. |
Principal Investigator: | Jeffrey Lancet, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Jeffrey Lancet, M.D. ) |
Study ID Numbers: | MCC-15025, INNO-305 WT-1, USF IRB-105946 |
Study First Received: | April 18, 2008 |
Last Updated: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00665002 History of Changes |
Health Authority: | United States: Institutional Review Board |
Myeloid Monocytic Hematopoietic Neoplasms |
Leukemia Hematologic Diseases Wilms' Tumor Interferons |
Myeloproliferative Disorders Wilms Tumor Bone Marrow Diseases |
Leukemia Neoplasms Neoplasms by Histologic Type |
Hematologic Diseases Myeloproliferative Disorders Bone Marrow Diseases |