Myelodysplastic Syndrome Clinical Trial
Vaccine Therapy in Treating Patients With Myelodysplastic Syndromes
Summary
RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with myelodysplastic syndromes (MDS).
Full Description
OBJECTIVES:
Primary
Determine the safety of GM-K562 cell vaccine in patients with myelodysplastic syndromes.
Determine the hematologic and cytogenetic response in patients treated with this vaccine.
Secondary
Determine if vaccination with GM-K562 cell vaccine can induce an immune response to common myeloid antigens (e.g., Wilms' tumor-1 [WT-1], survivin, or proteinase-3), as defined by a 30% increase from baseline in specific cytotoxic T-cells measured by Elispot assay, in patients with myelodysplastic syndromes.
Determine if immune response correlates with any clinical responses (e.g., hematologic response, resolution of cytogenetic abnormalities, or decrease in other parameters, such as WT-1 mRNA levels).
OUTLINE: This is an open-label study.
Patients receive GM-K562 cell vaccine subcutaneously once in weeks 0, 3, 6, 9, and 17 in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected periodically for correlative and biomarker studies. Samples are analyzed by cytogenetic studies, fluorescent in situ hybridization (FISH), and flow cytometry. Elispot is used to quantify cellular cytotoxic T-cell response to Wilms' tumor-1 (WT-1), survivin, and proteinase 3.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
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)
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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