3.15 With active infection are excluded. 
3.16 With active papilloma virus infection, including common warts or condyloma acuminata, will 
be excluded. 
3.17 Must have signed informed consent. 
4.0 TREATMENT PLAN 
i 
4. 1 After complete staging and satisfaction of eligibility criteria, patients will undergo lymph node 
biopsy by surgery or by mediastinoscopy. Approximately 1/2 of the tissue will be sent for culture and 
establishment of a cell line, 1/4 will be sent to Pathology for histologic review, and 1/4 will be 
desegregated and cryopreserved for later use as a reagent for studies of immunologic response after 
therapy with gene transfected cells. In the event that the patient’s tumor cells cannot be established in 
culture and stably transfected, the patient will go off study. 
4.2 All patients will be treated with combination chemotherapy administered every three weeks, 
with dosage adjustments made as necessary based on pretherapy blood counts. Each course of 
chemotherapy will consist of the following: 
Cyclophosphamide 1 gm/sq.M. IV on Day 1 
Doxorubicin 50 mg/sq.M. IV on Day 1 
Etoposide 120 mg/sq.M. IV on Days 1,2, and 3 
G-CSF (Filgrastim) 250 mcg/sq.M. subcutaneously daily starting on day 4 and continuing until day 
17 (unless nadir neutrophil count is > 10,000/mm3 after Day 12, in which case G-CSF will be 
discontinued). 
i 1 
Patients will receive a minimum of four cycles of chemotherapy if they are responding and a 
maximum of two cycles beyond their best response. Patients with stable disease/no response or 
progressive disease will be taken off study. Responding patients in good partial remission or in 
complete remission will be eligible for return of their gene-transfected cells. 
NOTE: These patients will receive approximately 3-4 months of chemotherapy. No further therapy 
will then be given, pending return of their gene transfected cells. We anticipate that the interval 
between the termination of chemotherapy and the opportunity to receive their gene-transfected cancer 
will be 2-3 months. In that interval, approximately 10-15% of patients in good partial remission or 
complete remission will relapse and need additional therapy. These patients will go off-study. The 
remainder should be in stable response to permit gene-therapy to occur at a time distant from the 
immunosuppressive effects of chemotherapy. Radiation therapy to the primary site of disease in the 
chest will be deferred until after completion of the gene therapy phase of this study, as discussed 
previously. 
I 
4.3 Establish new SCLC lines 
Tumor cells will be obtained from bone marrow aspiration, bronchoscopy, mediastinoscopy, or 
thoracentesis. Must have accessible tumor by lymph node biopsy or mediastinoscopy. 
Specimen Preparation: 
Bone marrow aspirate will be collected into a syringe containing preservative-free heparin, diluted l 
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Recombinant DNA Research, Volume 18 
