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

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.

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

Eligibility criteria:
inclusion criteria: * histologically and surgical confirmed diagnosis and stage of ib, iia, or iib non-small cell lung cancer (nsclc) according to the revised international system for staging lung cancer * primary surgical resection of lung cancer greater than or equal to 4 weeks and less than or equal to 3 years prior to the day 0 visit * no evidence of disease by standard diagnostic tests * chest x-ray and physical examination showing no active disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * wbc count greater than or equal to 3,000 cells/mm3 and anc greater than or equal to 1,500 cells/mm3 * hemoglobin value greater than or equal to 10.0 g/dl and a platelet count greater than or equal to 125,000 cells/mm3 * adequate renal function (defined as serum creatinine \<1.5 times the upper limit of normal for females and males) * normal hepatic function (defined as serum bilirubin \<1.5 times the upper limit of normal, ast \<2.5 times the upper limit of normal and alkaline phosphatase \<1.5 times the upper limit of normal) * ability to understand and willingness to sign an irb-approved written consent prior to study enrollment * female patients must be greater than or equal to 60 years of age, or greater than or equal to 5 years amenorrhea or surgically sterile * male patients who are capable of fathering a child and whose partners are capable of having a child must agree to use adequate contraception for 6 months after enrollment (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal ring or iud) * absolute cd4+ cell count of \>200 cells/mm3 exclusion criteria: * received pre- or post-operative radiotherapy * received prior biologic, immunologic, or gene therapy for cancer * received an investigational drug (new chemical entity) within three months of study entry * received antibiotics within 2 weeks of day 0 visit * received systemic or inhaled corticosteroids or immunosuppressive therapy within 4 weeks of day 0 visit (use of topical corticosteroids and/or eye drops containing glucocorticosteroids is acceptable) * history of active autoimmune diseases such as, but not limited to, systemic lupus erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or inflammatory bowel disease * history of bleeding in stools and/or diarrhea within 4 weeks of day 0 visit * history of anaphylaxis or severe allergic reaction to vaccines or unknown allergens * received any commercial vaccine within 2 weeks of day 0 visit * received a major organ allograft * current or previous diagnosis of paraneoplastic syndrome * evidence of a clinically significant active pulmonary infection, emphysema, fev1 less than or equal to 50% predicted, dlco less than or equal to 50% predicted, pulse oximetry less than or equal to 92% at the time of study entry * known to be hiv positive * results of virology screening indicate positive serology for hcv (hepatitis c virus) and/or hbsag (hepatitis b surface antigen). positive serology for hbv antibodies is allowed. * 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