K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome
- Determine the safety of GM-K562 cell vaccine in patients with myelodysplastic
- Determine the hematologic and cytogenetic response in patients treated with this
- 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.
Masking: Open Label, Primary Purpose: Treatment
B. Douglas Smith, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|