Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy
- Determine the overall survival in patients with locally advanced non-small cell lung
cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells
after standard therapy.
- Assess the safety and immunological efficacy of this regimen in terms of inducing or
boosting a mutant p53-specific immune response in this patient population.
OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene
mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant
p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks.
Patients achieving an immune response with no evidence of progressive disease may receive
additional vaccinations every 2 months for a maximum of 10 immunizations.
Patients are followed for 5 years.
PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued
for this study.
Primary Purpose: Treatment
Disease-free survival by CTEP CTC v2.x
Jay A. Berzofsky, MD, PhD
NCI - Vaccine Branch
United States: Federal Government
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|