Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Cancer Centers of Florida
🇺🇸Ocoee, Florida, United States
Mary Crowley Medical Research Clinic
🇺🇸Dallas, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States