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Tracking Information | |||||||||
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First Received Date † | February 9, 2007 | ||||||||
Last Updated Date | December 23, 2008 | ||||||||
Start Date † | February 2007 | ||||||||
Current Primary Outcome Measures † |
The primary objectives will to evaluate the efficacy and toxicity associated with the immunotherapy approach of lymphodepletion, lymphocyte infusion, and WT1 vaccination in selected patients with hematological malignancies. [ Time Frame: 12 weeks after last dose of vaccine ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00433745 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Secondary objectives will include evaluation of disease response by following the numbers of WT1 expressing cells in blood, hematological measurements (reduction in marrow blast cells, changes in blood counts), transfusion de... [ Time Frame: 12 weeks after last dose of vaccine ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Vaccination for Patients With High Risk Cancers of the Blood | ||||||||
Official Title † | WTI Peptide Vaccination for Patients With High Risk Hematological Malignancies | ||||||||
Brief Summary | This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number of immune cells responding to the cancer and thereby slow progression of the illness, improve blood counts, reduce the need for transfusions of blood and platelets, or even achieve a disease remission. The vaccine contains part of a protein that is produced in large amounts by cells of patients with these cancers and an added substance called Montanide that helps the immune system respond to the vaccine. Sargramostim, another substances that boosts the immune response, is also given. Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, chest x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test. Participants undergo the following:
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Detailed Description | Leukemias and the related disorders myelodysplastic syndrome and myeloproliferative diseases represent a wide group of bone marrow stem cell malignancies. Some patients can be cured with chemotherapy or by allogeneic stem cell transplantation. However, standard treatment approaches are not effective for patients who become refractory to chemotherapy, those who relapse after transplantation and those with progressive disease. The management of such patients remains unsatisfactory and requires new treatment approaches other than chemotherapy. The immunological graft-versus-leukemia (GVL) effect seen after allogeneic stem cell transplantation suggests that stimulating the patient's own T cell responses to hematological malignancies might also retard disease progression and even achieve disease remissions. WT1 was identified as a target vaccine antigen because this antigen is over-expressed by CD34 plus stem cells of most patients with myeloid and lymphoid malignancies but not by normal marrow cells. An HLA-A0201 restricted peptide derived from the WT protein is anticipated to induce T cell response against MDS and leukemic cells while sparing normal cells. Of note, about 40% of the population is HLA-A0201 positive. Therefore we propose this Phase II trial, the second in a series of planned peptide vaccine research, which will evaluate the safety associated with an immunotherapy approach of lymphodepletion, lymphocyte infusion, and WT1 vaccination in select patients diagnosed with MDS, AML, ALL and CML. The WT1 vaccination will comprise of 9 doses of WT-1 peptide vaccines (in Montanide adjuvant) administered concomitantly with GM-CSF (Sargramostim). The primary objectives will be to evaluate the efficacy and toxicity associated with the immunotherapy approach of lymphodepletion, lymphocyte infusion, and WT1 vaccination in selected patients with hematological malignancies. Secondary objectives will include evaluation of disease response by following the numbers of WT1 expressing cells in blood, hematological measurements (reduction in marrow blast cells, changes in blood counts), transfusion dependence, and time to disease progression and survival. The primary endpoint will be the side effects of treatment (toxicity and number of circulating WT1 specific T cells (efficacy ) measured through week 16 of the study (7 weeks after the last dose of vaccine). |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † |
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Intervention † | Drug: WR 1 and PR 1 Peptide Vaccine | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 24 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † |
Inclusion Criteria Donor (for post transplant subjects without available DLI cells):
EXCLUSION CRITERIA:
Exclusion Criteria-Donor (any of the following):
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Gender | Both | ||||||||
Ages | 18 Years to 85 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00433745 | ||||||||
Responsible Party | A. John Barrett, M.D./National Heart, Lung, and Blood Institute, National Institutes of Health | ||||||||
Secondary IDs †† | 07-H-0091 | ||||||||
Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
Collaborators †† | |||||||||
Investigators † | |||||||||
Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | November 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |