Safety of Peptide Vaccination for Patients With Myelodysplastic Syndrome
Myelodysplastic Syndrome (MDS)
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Myelodyplastic Syndrome (MDS), Wilm's tumor-1, Proteinase-3, Vaccine Therapy, Acute Myeloid Leukemia, Chronic Myeloid Leukemias, Myelodysplastic Syndrome, MDS
Eligibility Criteria
INCLUSION CRITERIA: Diagnosed with FAB subtypes RA, RARS MDS (Low Risk) OR Diagnosed with AML and in complete remission within 5 years of treatment with less than 5 percent marrow blasts OR Diagnosed with CML In chronic phase OR Diagnosed with MDS, AML or CML and are between 6 months-3 years following allogeneic SCT who fulfill the following criteria: 100 percent donor engraftment, less than 5 percent blasts in marrow normal marrow cellularity HLA-A0201 positive at one allele Ages 18 - 85 years old EXCLUSION CRITERIA: Hypoplastic MDS Relapsed AML CML in accelerated phase or blast crisis Relapsed MDS, AML or CML following hematopoietic stem cell transplantation Hb less than 9 g/dl, neutrophil count less than 1 times 10(9)/1, and/ or platelet count less than 75 times 10(9)/1 Hypocellular bone marrow History of Wegener's granulomatosis Serologic antibody against proteinase-3 (ANCA positive) Previous allergic reaction to montanide adjuvant Positive test for HIV Treatment with systemic corticosteroids within 14 days prior to study entry Co-morbidity of such severity that it would preclude the subject's ability to tolerate protocol therapy Predicted survival less than 28 days Pregnant or breast feeding (All female subjects must have a urine pregnancy test within 1 week prior to vaccine administration) Enrolled in another drug or vaccine clinical trial during the study period Inability to comprehend the investigational nature of the study and provide informed consent
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike