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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00019929
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-11
• Study Completion: 2005-12
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival by CTEP CTC v2.x
Toxicity by CTEP CTC v2.x
Disease-free survival by CTEP CTC v2.x

Secondary Outcome Measures

Name	Time	Method
Immunological response by ELISPOT before and 2 weeks after last vaccine

Trial Locations

Locations (2)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States