Gene Therapy for Meningeal Carcinomatosis 
noted. These screening evaluations must be reviewed prior to study treatment. 
5.11 Objective Signs and Symptoms : include vital signs (blood pressure, pulse, temperature and 
respirations) weight and height (Screening and repeat daily in inpatients). 
5.12 History and Physical Examination : Screening, repeat targeted physical examination on Day 
0 
5.13 Chest X-Ray : CXR within the last 30 days to exclude acute inflammatory process, unless 
new symptoms suggest that this be repeated prior to dosing (Screening). Presence of lung 
metastases do not exclude patients from enrollment in the protocol. 
5.14 Electrocardiogram (ECG): ECG must be normal within 30 days unless new symptoms 
suggest this be repeated prior to dosing (Screening) 
5.15 Urinalysis : Routine urinalysis including a 24-hour creatinine clearance (Screening and 
repeat Day 0 ) 
5.16 Serum Chemistries : include uric acid, calcium, phosphorus, magnesium, amylase, 
triglycerides, transaminases (SGOT, SGPT), alkaline phosphatase, LDH, total bilirubin, BUN, 
creatinine, albumin, total protein, electrolytes, and glucose (Screening and repeat Day 0 ) 
5.17 Hematology : Complete blood count (CBC), differential, platelets, and coagulation tests 
should include PT (Prothrombin Time), PTT (Partial Thromboplastin Time), and fibrinogen 
(Screening and repeat Day 0 ). 
5.18 Pregnancy Test : Serum pregnancy test must be negative within 7 days prior to Day 0, or 
between study days -7 and 0. 
5.191 Freezing Specimens : Additional serum, plasma, and blood cells will be separated and 
frozen at baseline (day -1 to day 1, prior to treatment). See appendix IX for appropriate 
processing, storage/shipping of study materials.) 
5.2 Interval Evaluations 
5.21 Objective signs and symptoms : Vital signs (blood pressure, pulse, temperature and 
respirations) will be done three times daily while hospitalized at the NIH Clinical Center. 
5.22 Physical Examination : Target physical exam will be done daily. 
5.23 Serum and Urine Chemistries : uric acid, calcium, phosphorus, magnesium, amylase, 
triglycerides, transaminases (SGOT, SGPT), alkaline phosphatase, LDH, total bilirubin, BUN, 
creatinine, albumin, total protein, electrolytes, and glucose will be done weekly during GCV 
treatment. Creatinine clearance will be checked before and after GCV treatment. 
5.24 Hematology : Complete blood count (CBC), differential, platelets, and coagulation 
tests should include PT (Prothrombin Time), PTT (Partial Thromboplastin Time), and fibrinogen 
will be done every three days. 
5.25 Freezing Specimens : Additional serum, plasma, and cells will be separated and 
frozen at the conclusion of GCV treatment. 
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