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.

Condition	Treatment or Intervention	Phase
Non-small cell lung cancer	Vaccine: Recombinant DNA- pVAX/L523S  Vaccine: Recombinant adenovirus- Ad/L523S	Phase I

Further Study Details: 

Expected Total Enrollment:  9

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Florida
      Cancer Centers of Florida, Ocoee,  Florida,  34761,  United States; Recruiting
Texas
      Mary Crowley Medical Research Clinic, Dallas,  Texas,  75246,  United States; Recruiting
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States; Recruiting
Washington
      Cancer Care Northwest, Spokane,  Washington,  99218,  United States; Recruiting
      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States; Recruiting

Study ID Numbers:  CCL5001-01
Record last reviewed:  November 2004
Last Updated:  November 5, 2004
Record first received:  June 17, 2003
ClinicalTrials.gov Identifier:  NCT00062907
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08