Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Official Title: 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

Study ID: NCT00019929

Conditions

Lung Cancer

Interventions

mutant p53 peptide pulsed dendritic cell vaccine

adjuvant therapy

Study Description

Brief Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.

Detailed Description: OBJECTIVES: * 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.