Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
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.
Biological: mutant p53 peptide pulsed dendritic cell vaccine
Procedure: adjuvant therapy
|Study Design:||Primary Purpose: Treatment|
|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|
- Disease-free survival by CTEP CTC v2.x [ Designated as safety issue: No ]
- Overall survival by CTEP CTC v2.x [ Designated as safety issue: No ]
- Toxicity by CTEP CTC v2.x [ Designated as safety issue: Yes ]
- Immunological response by ELISPOT before and 2 weeks after last vaccine [ Designated as safety issue: No ]
|Study Start Date:||August 2000|
|Study Completion Date:||December 2005|
- 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.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Jay A. Berzofsky, MD, PhD||NCI - Vaccine Branch|