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