Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00019929|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: mutant p53 peptide pulsed dendritic cell vaccine Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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 Start Date :||August 2000|
|Actual Study Completion Date :||December 2005|
- Disease-free survival by CTEP CTC v2.x
- Overall survival by CTEP CTC v2.x
- Toxicity by CTEP CTC v2.x
- Immunological response by ELISPOT before and 2 weeks after last vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019929
|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|