2.0 PROPOSAL PROTOCOLS AND EXPERIMENTAL DETAILS 
In patients with limited stage small cell lung cancer, to: 
2.1 Determine the toxicity and safety of administering the patients’ own gene-transfected cancer 
cells that express 11-2. 
2.2 Demonstrate the generation of local and systemic tumor-specific T effector lymphocytes 
capable of lysing the gene-transfected and nontransfected cancer cells. 
2.3 Assess the patients for evidence of a clinical response to therapy. 
2.4 Develop the framework for subsequent studies of gene-transfection directed at enhancing the 
intensity, durability and specificity of the autologous immunologic response to cancer. 
3.0 ELIGIBILITY CRITERIA FOR ENTRY ON STUDY 
Because it is essential that we select patients with an opportunity to remain in response long enough 
for unimpeded therapy with the gene transfected cells, we will exclude patients from study with poor 
prognostic features. In LD SCLC, established adverse prognostic variables include poor performance 
status, extensive weight loss, age J> 70 years, elevated LDH (serum lactic dehydrogenase level), and 
the presence of a pleural effusion (78). The eligibility criteria listed below reflect these considerations, 
and are geared to select a favorable subset of LD SCLC who will still be eligible for gene therapy 4-6 
months after initial biopsy for cell culture. 
Patients: 
3. 1 Must have a histologically or cytologically verified diagnosis of SCLC of Limited Disease Stage 
as determined by chest X-ray, CT scans of the chest and abdomen, CT or MRI scans of the 
brain, bone scan, and bone marrow examination. 
3.2 Who have a pleural effusion or an elevated LDH are excluded from study. 
3.3 Must have accessible tumor by lymph node biopsy or mediastinoscopy. 
3.4 Must be J> 18 years old. 
3.5 With a history of myocardial infarction within the preceding 6 months or with angina are 
excluded. Patients with a past history of cardiac disease, must have a normal cardiac ejection 
fraction by MUG A scan. 
3.6 Must have a white blood cell count of _> 3,000/mm 3 and platelet count _> 100,000/mm 3 . 
3.7 Must have serum creatinine clearance >_ 70 ml/min by determination or calculation from serum 
creatinine. 
3.8 Must have a bilirubin < 1.2 mg/dl and transaminases and alkaline phosphatase < 2 times 
normal. 
3.9 Must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 (no 
physical limitations) or 1 (only restricted from strenuous activity). 
3.10 Who have lost >5% of their premorbid weight are excluded. 
3.11 Who are women may not be pregnant or lactating. All patients with reproductive potential must 
agree to use an effective contraceptive method for the duration of the study. 
3„12 With prior or current anti-tumor therapy are excluded. 
3.13 With any prior malignancy, except for adequately treated basal or squamous cell skin cancer or 
in situ cervical cancer, are excluded. 
3.14 With AIDS or HIV infection are excluded. 
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