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.

NCT00062907

Conditions

1. Non-Small Cell Lung Cancer

Interventions

1. Biological: Recombinant DNA- pVAX/L523S
2. Biological: Recombinant adenovirus- Ad/L523S

MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung

HPO:Neoplasm of the lung Non-small cell lung carcinoma

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. --- L523S ---

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

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

The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). --- L523S ---

The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). --- L523S --- --- L523S ---

The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients. --- L523S ---

- History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured - Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment - Patient is lactating - Staging classification of TX or NX or MX - Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung 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. --- L523S ---

- History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured - Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment - Patient is lactating - Staging classification of TX or NX or MX - Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung 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. --- L523S --- --- 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 --- 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 --- L523S --- --- 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 --- L523S --- --- L523S --- --- 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 --- L523S --- --- L523S --- --- L523S --- --- 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 --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- 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 --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- 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 --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- L523S --- --- L523S ---