Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title: Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.

Clinical Trial Description

The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAX/L523S and two doses of Ad/L523S.

The secondary objectives of the study are:

• To provide initial evidence as to whether CD8+ and CD4+ T cell responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S

• To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S

• To investigate the extent to which dose escalation of Ad/L523S affects the elicited immune response ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT00062907
• Study type: Interventional
• Source: Corixa Corporation
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2003