Vaccine Therapy in Treating Patients With Myelodysplastic Syndromes
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, refractory cytopenia with multilineage dysplasia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed myelodysplastic syndromes (MDS), including any of the following: Refractory anemia (RA) RA with ringed sideroblasts Refractory cytopenias with multilineage dysplasia (RCMD) RCMD with ringed sideroblasts RA with excess blasts 1 (5-9% blasts) RA with excess blasts 2 (10-19% blasts) Must have poor-risk MDS, defined by the following: At least 2 lineages involved Unfavorable cytogenetics (i.e., abnormalities of chromosome 5 or 7, 11q23, t[6;9], trisomy 8, inv3, or multiple/complex karyotype) Transfusion requirement of > 2 units of packed red blood cells monthly No chronic myelomonocytic leukemia No transformation to acute myeloid leukemia PATIENT CHARACTERISTICS: ECOG performance status 0-2 Creatinine < 2.5 mg/dL Bilirubin < 2.5 mg/dL (unless due to Gilbert's syndrome) Room air oxygen saturation ≥ 94% at rest Fertile patients must use effective contraception Negative pregnancy test No other malignancy within the past 5 years except in situ cervical cancer or adequately treated nonmelanoma skin cancer No active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressants including, but not limited to, any of the following: Autoimmune hemolytic anemia Idiopathic thrombocytopenia purpura Inflammatory bowel disease Vasculitis Thyroiditis Rheumatic illnesses No known HIV serum antibody positivity No other disease requiring long-term corticosteroids or other immunosuppressants, such as severe chronic obstructive pulmonary disease or asthma PRIOR CONCURRENT THERAPY: At least 2 weeks since prior systemic corticosteroids or other immunosuppressants (e.g., cyclosporine, azathioprine, tacrolimus, or mycophenolate mofetil) At least 3 weeks since prior growth factors At least 2 months since prior azacitidine for MDS No prior bone marrow or other organ transplantation No concurrent cytotoxic-based therapy for MDS No other concurrent growth factors, including epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Experimental
K562/GM-CSF cell vaccine
Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.