5.3 Screening 
The patient will be thoroughly informed of the overall aspects and procedures to ensure 
his/her willingness to undergo surgery for TIL retrieval and comply with the visit and 
activities schedule. As part of the complete medical evaluation to determine the 
eligibility of a given subject, the potential patient will undergo extensive history and 
physical examination prior to the surgery. These data are found in the Case Report 
Forms and include the following: 
5.3.1 The physical examination will include patient (medical) history, Kamofsky 
Performance status, vital signs, neurological exam, chest X-ray, tumor 
assessment, CT or MRI brain scan, EKG, cardiac evaluation, and pregnancy test 
(if premenopausal female). 
5.3.2 Laboratory studies will include CBC with differential, platelet counts, coagulation 
profile (PT, PTT), urinalysis, serum chemistry, including glucose, BUN, 
creatinine, total protein, albumin, total bilirubin, SGPT, SGOT, LDH, alkaline 
phosphatase, calcium, uric acid, sodium, potassium, chloride, C02, and 
phosphorus. 
5.3.3 If the physician and patient both agree, the patient will sign the informed 
consents. Separate informed consents will be obtained for (a) entry surgical 
procedures, (b) TIL and PBL administration, and retroviral transduction, and (c) 
any biopsies. 
5.4 Withdrawal From Study Patients: 
Patients will be advised that they may voluntarily withdraw from the study at any time 
and will be instructed to notify the investigator. Patients may choose to withdraw for any 
reason(s). Patients are not obligated to reveal their reason(s) for withdrawal. It is 
understood that an excessive rate of withdrawals may adversely impact the analysis of 
data and interpretation of results, therefore unnecessary withdrawal of study subjects is 
to be avoided. Should a patient decide to withdraw every effort will be made to complete 
and report an explanation provided for the study subject’s withdrawal. 
Additionally, the patients may withdraw or be withdrawn from the study for the following 
reasons: 
5.4.1 The patients may relocate to another geographic area that requires a change of a 
physician. Attempts will be made to secure cooperation from the new physician. 
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