Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC).

Pts must have radiologic features and clinical presentation consistent w/BAC (diffuse or ground glass appearance) OR adeno ca w/BAC features OR BAC w/focal invasion; Stage IIIB (due to malignant pleural effusion) or Stage IV; Pts must have measurable or non-measurable disease by Chest CT (incl. liver and adrenals) or accompanied by abdominal CT in which they are visualized both prior to and after tumor procurement for vaccine; If pts require thorascopic surgery or thoracotomy is planned, pts must have arterial blood gas PACO2 < 45 mm Hg; predicted post-resection FEV1 must be >/= 1.0L; pre-op DLCO must be > 50% of predicted; if pre-op FEV1 is < 2.0, a quantitative ventilation/perfusion scan must be ordered; Prior biologic, chemotherapy or RT must be completed 4 weeks prior and disease assessment done afterward (Exception: Pts may remain on EGFR inhibitors until two weeks prior to Reg #2); Disease must be present outside port, or have clear progression of previously irradiated site; Pts w/prior regional chemotherapy administered through pulmonary artery are not eligible, if resection of tumor in treated lobe is planned; Pts requiring a surgical procedure must demonstrate pulmonary artery systolic pressues < 40 mm Hg and LVEF > 40% by echocardiogram; Numeric values of pulmonary artery pressure are not necessary if the patient is determined to have no tricuspid regurgitation; Pts must be able to read and understand English or Spanish to participate in QOL portion (may be registered to receive treatment in unable to participate in QOL); Pts must be neurologically stable or have asymptomatic, treated brain mets; If brain mets are to be used for tumor procurement, surgery must take place after registration; Pts may have received prior surgery provided that at least 7 days have elapsed and pts are recovered from all surgical toxicities; Pts must have tumor accessible for procurement via thorocentesis (at least 600 ml) or surgical procedure (prefer solid tumors >/= 1 x 1 cm; Zubrod PS 0-1; Pts must have completed QOL questionnaires (see Section 5.23); ANC >/= 1,500, platelets >/= 100,000, CD4 count > 200, serum bilirubin </= 1.5 x IULN, SGOT or SGPT and alkaline phosphatase </= 2.5 X IULN; If liver mets are present, SGOT or SGPT must be </= 5 x IULN and serum bilirubin </= 3 X IULN; If bone mets are present, alkaline phosphatase must be </= 5 x IULN; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; Pts must agree to have blood specimens submitted for immune monitoring per Section 15.1; Pts must not have had prior gene therapy, including any adenoviral-based therapy; Pts not be currently receiving or planning to receive any other non-protocol treatment for BAC; Pts must not be receiving immunosuppressants or planning to receive steroids; Pts must not have received treatment with systemic corticosteroids w/in 14 days of registration; Pts must not have active immune or autoimmune disease such as systemic lupus, erythematosis, sarcoiditis, RA, glomerulonephritis or vasculitis; Pts must not have known hypersensitivity to GM-CSF, pentastarch, gentamicin, human serum albumin, dimethysulfoxide, porcine trypsin, fetal bovine serum, recombinant benzonase, or to any other component of the vaccine or CG6444 adenoviral vector; Pts must not have significant baseline hypoxia (O2 sat > 90% or < 2 L/min supplemental O2 via nasal cannula); Pts must not have active or impending spinal cord compression or evidence of pericardial tamponade; Pts must not have prior malignancy except: treated basal cell or squamous cell ca, in situ cervical, Stage I or II ca in complete remission and disease-free from any ca for 5 yrs; Pts must not have post obstructive pneumonia or other serious infection at the time of registration or any uncontrolled intercurrent illness including, but not limited to, symptomatic CHF, pulmonary hypertenstion, unstable angina, cardiac arrhythmia, poor nutritional status, bleeding or thrombolic disorders, or psychiatric illness/social situations that would limit compliance or increase surgical risk (see Section 5.19); Pts must not require chronic anti-coagulation therapy; Pts must not have had prior RT to the tumor mass targeted for resection; Institutions must have IRB approval of S9925 and pts must be offered participation in S9925; Register patients separately to receive institutional credit for specimen submission (see Section 15.3).