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

Fecha de inicio: 1 de marzo de 2004

DISEASE CHARACTERISTICS: * Diagnosis\* of 1 of the following by radiological features and clinical presentation: * Bronchoalveolar carcinoma (BAC) * Diffuse or ground glass appearance * Adenocarcinoma with bronchoalveolar features * BAC with focal invasion NOTE: \*Histological confirmation (excluding fine needle aspiration or bronchial brushings or washings) is required after the tumor tissue has been procured and the vaccine has been produced * Selected stage IIIB (due to malignant pleural effusion) OR stage IV disease * Measurable or nonmeasurable disease (e.g., diffuse infiltrative process) by CT scan of the chest both before and after tumor tissue procurement for vaccine * Not a candidate for curative resection * Tumor accessible for tissue procurement via thoracentesis or a surgical procedure * If a pleural effusion is the source of tumor tissue, at least 600 mL of fluid must be available for vaccine manufacture * Resection of brain metastases may be used for vaccine processing * Surgery must be done after study entry * Asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastases allowed provided the patient is neurologically stable * No active or impending spinal cord compression or evidence of pericardial tamponade PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * CD4 count greater than 200/mm\^3 * No bleeding disorder Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) * SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases are present) Renal * Not specified Cardiovascular * See Disease Characteristics * Patients requiring surgery for tumor tissue procurement must meet the following criteria: * Pulmonary artery systolic pressure \< 40 mm Hg by echocardiogram\* * LVEF \> 40% * No symptomatic congestive heart failure * No thrombolic disorder * No unstable angina pectoris * No cardiac arrhythmia NOTE: \*Not needed if patient has no tricuspid regurgitation Pulmonary * No pulmonary hypertension * No significant baseline hypoxia (i.e., O_2 saturation less than 90% OR requires greater than 2 L/min of supplemental O_2 via nasal cannula) by an oxygen saturation test * No postobstructive pneumonia * Patients requiring thoracoscopic surgery or thoracotomy for tumor tissue procurement must meet the following criteria: * Alveolar partial pressure of CO_2 \< 45 mm Hg * Predicted postresection FEV_1 ≥ 1.0 L * DLCO \> 50% of predicted Immunologic * No active immune or autoimmune disease * No systemic lupus erythematosus * No sarcoiditis * No rheumatoid arthritis * No glomerulonephritis * No vasculitis * No serious infection * No hypersensitivity to any of the following: * Sargramostim (GM-CSF) * Pentastarch * Gentamicin * Human serum albumin * Dimethyl sulfoxide * Porcine trypsin * Fetal bovine serum * Recombinant benzonase * Other components of the vaccine or CG6444 adenoviral vector used in this study Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No poor nutritional status * No psychiatric illness or social situation that would preclude study compliance or increase operative risk * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy * No prior gene therapy, including adenoviral-based therapy Chemotherapy * More than 4 weeks since prior chemotherapy * No prior regional chemotherapy administered through the pulmonary artery (if resection of the tumor in the treated lobe is planned) Endocrine therapy * More than 14 days since prior systemic corticosteroids * No concurrent steroids Radiotherapy * See Disease Characteistics * More than 4 weeks since prior radiotherapy * Disease must be outside the areas of prior radiotherapy OR clear progression at prior irradiated sites must be documented * No prior radiotherapy to the tumor mass targeted for resection Surgery * See Disease Characteristics * More than 7 days since prior surgery and recovered Other * More than 2 weeks since prior epidermal growth factor receptor inhibitors * No other concurrent nonprotocol-specified treatment * No concurrent immunosuppressants * No concurrent chronic anticoagulation therapy