Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT00074295
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00074295
Study Brief:
Protocol Section:
NCT00074295