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

Phase 1

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00062907
• Lead Sponsor: Corixa Corporation

Brief 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.

Detailed 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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-06-17
• Study First Submitted QC: 2003-06-18
• Study First Posted: 2003-06-19
• Status Verified: 2004-11
• Last Update Submitted: 2006-12-05
• Last Update Posted: 2006-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (5)

Cancer Centers of Florida; 🇺🇸 Ocoee, Florida, United States

Mary Crowley Medical Research Clinic; 🇺🇸 Dallas, Texas, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States