Myelodysplastic Syndrome (MDS) Clinical Trial
— WT-1Official title:
A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CmML, ALL, MDS, and B Cell Malignancies
Verified date | December 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the safety and effectiveness of administering Wilms tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made in a laboratory to be like the peptides that can be found in cancer. These peptides are intended to be given as a "vaccine" to activate the immune cells in a person to attack his/her cancer. These peptides are mixed with an oily substance called Montanide ISA-51 and a white cell growth factor called Granulocyte-macrophage colony-stimulating factor (GM-CSF) which may help make the immune response stronger.
Status | Terminated |
Enrollment | 8 |
Est. completion date | October 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: There are two subgroups of patients: Those undergoing autologous stem cell transplantation and those undergoing allogeneic stem cell transplantation. Autologous transplant subgroup: -Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who will be undergoing autologous stem cell transplantation. Allogeneic transplantation subgroup: -Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who have undergone allogeneic stem cell transplantation. There is no limitation on whether myeloablative or non-myeloablative chemotherapy is administered. A 3/6 or greater match is required for patients who have had an allogeneic stem cell transplant. Both subgroups: - Subject must be one of the following HLA types: HLA A2, A24, DR15 or DRw53 (includes HLA-DR4, -DR7, and DRw9) - Karnofsky performance status must be greater than or equal to 70%. - Age = 18 years. - Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines. - Patient must agree to use adequate contraception defined as: for women, one of the following (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); for men, one of the following: (1) surgical sterilization, or (2) a condom used with a spermicide. - In order to receive their immunizations, subjects should be: For autologous transplants: - At least 2 weeks from prior chemotherapy. - Injections 1 and 2 must be completed prior to administration of any growth factor mobilization - Injections 3, 4, 5, and 6, to resume 2 or more weeks from the time of their stem cell infusion if there has been no Grade 3 or 4 non-hematologic, major organ toxicity within the preceding 1 week. Non-major organ toxicities must have resolved to grade 2 or less. For allogeneic transplants, - At least 2 weeks from the time of their stem cell infusion. - Without Grade 3 or 4 non-hematologic major organ toxicity within the preceding 1 week; non major organ toxicities must have resolved to grade 2 or less. - We will require demonstration of >50% donor myeloid hematopoiesis, based on microsatellite polymorphisms, prior to enrolling the patients with MDS on the study. - Adequate laboratory data as follows: Hematologic function: WBC = 3000/microliter, hemoglobin = 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets = 50,000/microliter ((may transfuse). Renal and hepatic function: serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except a bilirubin of <2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT < 2 x upper limit of normal. - Subjects must have a CD4+ count is > 200/mm. There is no specified requirement for CD8+ T cell count. - Urine protein/creatinine ratio (UPC) must be less than 1. Exclusion Criteria: - Corticosteroid (greater than 10mg per day of prednisone or an equipotent dose of another corticosteroid) or other immunosuppressive therapy within the prior 1 week. - Pregnant women and nursing mothers. - Current or prior history of brain metastases. - More than 12 months since their stem cell transplant. - HIV +, hepatitis BsAg +, Hepatitis C Ab+. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Michael Morse, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Feasibility | To determine the safety and feasibility of administering WT1 peptides to subjects who have undergone autologous or allogeneic stem cell transplantation for AML, CML, ALL, B cell malignancies and myelodysplastic syndrome. | 2 years | No |
Secondary | Immune Response | To evaluate the immune response to immunizations. | 2 years | No |
Secondary | Efficacy (PFS and OS) | To obtain preliminary data on efficacy (PFS and OS) following immunization in those with available data. | 2 years | No |
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