NCT00361296

Vaccine Therapy in Treating Patients With Myelodysplastic Syndromes

K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	K562/GM-CSF cell vaccine

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2006-08-08
• Last updated: 2023-03-23
• Results posted: 2018-11-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study