but this may not be successful in all cases. 
5.4.2 The patient may be unable to continue participation in the study due to some 
significant, though unrelated condition or accident. 
5.4.3 Female patients becoming pregnant after inclusion into the study will notify the 
investigator and will be withdrawn from the study. 
5.5 Criteria for Replacing a Patient 
5.5.1 Cell Expansion: Those patients for whom it was not possible to expand TIL up 
to 10 9 may receive all cells obtained after cell expansion appears to have stopped. 
The subjects will be evaluated according to the protocol; however, the data will 
not be included in the final analysis but will be reported separately. 
5.5.2 Death before completion of rIL-2 infusion 
5.5.3 Major protocol violation : Patients who receive other antitumor therapy in addition 
to rIL-2 will be replaced and the data will be analyzed separately. 
5.5.4 Lost to follow-up: Those patients for whom there is inadequate information to 
judge tumor response because of loss of contact despite repeated attempts to obtain 
information. 
5.5.5 Grade 2 or Grade 3 toxicity recurring after resumption of rIL-2 at 10 percent of 
the original dose. 
5.5.6 All patients demonstrating unacceptable toxicity to IFNaA (applicable to study 
subjects 16-30). 
6. STUDY POPULATION 
Patients with metastatic cancer with tumor suitable for surgical resection will be entered 
into this study. 
6. 1 INCLUSION CRITERIA 
6.1.1 Study subjects must have a histologically confirmed diagnosis of metastatic 
cancer and give consent for entry surgical procedure and the regimen of 
this protocol. Patients must have at least one subcutaneous deposit of 
metastatic tumor available for biopsy. 
6.1.2 Age 18 or older 
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Recombinant DNA Research, Volume 15 
