S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer

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