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