Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer

Inclusion Criteria

• Histologically confirmed metastatic adenocarcinoma of the lung
• Patients must have received and completed first line therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
• No external beam radiation therapy within 2 weeks of first vaccine administration
• No stereotactic radiation therapy within 3 days of first vaccine
• No targeted therapy within 2 weeks of first vaccine administration
• No immunomodulatory therapy within 2 weeks of first vaccine administration
• No chemotherapy within 4 weeks of first vaccine administration
• During Screening period, no steroid therapy within 4 weeks of first vaccine administration
• Patient's written informed consent
• Adequate organ function (measured within a week of beginning treatment):
• White blood count (WBC) > 3, 000/mm³ and absolute neutrophil count (ANC) >/= 1500/mm³
• Platelets > 100,000/mm³
• Hematocrit > 25%
• Bilirubin 60 mL/min
• Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.
• Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.

Exclusion Criteria

• Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.
• Any acute medical problems requiring active intervention
• Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
• Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus [HIV] infection)
• Any known pre-existing autoimmune disorder
• History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)
• Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment
• Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).
• Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
• Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
• Patients who at the discretion of the investigator are deemed to have rapidly progressive disease