Protocol ID93-008 
Page 10 
“second look" after first line chemotherapy, tumors may be decreasing, stable or 
increasing). Prior taxol exposure will not exclude patients. 
4.3 Tissue samples for preparing TIL will be obtained from two tumor biopsies or 
irrigation of the abdominal cavity at surgical exploration or laparoscopy as described 
in protocol ID92-015 (T92-0093). Patients will become eligible for the marker 
protocol once cultured CD8+ T cells are obtained. 
4.4 At least 16 years of age. 
4.5 Ambulatory with good performance status (ECOG PS 0-1; Kamofsky PS 100-70%). 
4.6 Adequate organ function as defined by: 
4.6.1 AGC > 1500/m2, platelet count > 100, OOO/mm^. 
4.6.2 Bilirubin < 1.5; creatinine <1,5 mg/dl or calculated creatinine clearance > 
60 ml/min. 
4.6.3 No evidence of congestive heart failure, symptoms of coronary artery disease, 
serious cardiac arrhythmias or evidence of prior myocardial infarction. 
4.6.4 Adequate pulmonary reserve. Pulmonary function will be performed if 
clinically indicated in consultation with the Department of Internal Medicine. 
An FEVi > 2.0 liters or > 75% of predicted for height and age will be 
considered as minimum acceptable criteria for patient entry. These have 
been the eligibility requirements for NCI sponsored trials using rIL-2/LAK. 
We do not however anticipate pulmonary or cardiovascular problems with 
the current dose levels of IP rIL-2 which is below the MTD for rIL-2 (Chiron- 
CETUS) by the IP route. 
4.7 No evidence of active infection which requires antibiotic therapy. Patients may 
become eligible after the infection is controlled. 
4.8 No contraindication to the use of pressor agents. 
4.9 Patients must have recovered from toxic effects of prior therapy. At least 4 weeks 
should have elapsed from prior chemotherapy or hormones and at least three months 
from radiation therapy before treatment with TIL. 
4.10 Patients must be negative for HIV antibody by ELISA (or negative by Western blot if 
ELISA is positive) and negative for HBg Ag. 
4. 1 1 The patient must give signed informed consent prior to the initiation of therapy or 
obtaining samples. 
4. 12 Exclusion Criteria 
4. 12. 1 Patients who have extensive adhesions preventing free flow of fluid. 
4.12.2 Intestinal dysfunction or uncorrectable intestinal obstruction due to disease 
or adhesions. 
4.12.3 Patients with clinical disease who are good candidates for carboplatin 
relnduction. 
4. 12.4 Prior therapy with IP lL-2. 
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Recombinant DNA Research, Volume 19 
