Gene Therapy for Meningeal Carcinomatosis 
and abnormal liver function. Fever and chills will be treated with acetaminophen (650 mg every 4 
hours) and rash with diphenhydramine (50 mg every 6 hours). 
There are a number of other possible toxicities related to GCV administration. These 
toxicities have generally occurred in immunosuppressed, ill individuals receiving long term GCV 
administration. Our treatment protocol will use a dose (lOmg/kg/day) that is known to be tolerated 
in non-infected patients and the GCV will be administered for only 14 days. These differences in 
patient population and treatment duration should minimize the likelihood of the development of the 
toxicities cited. 
4.0 Patient Selection 
4.1 Inclusion Criteria 
Patients must meet the following criteria within 30 days prior to study entry (Day 0) unless 
otherwise noted: 
4. 1 1 Men or women, age >18 years of age 
4.12 Established diagnosis of LMC confirmed by CSF cytology 
4.13 Only patients who have failed standard therapy for LMC will be considered for the 
protocol. Failure will be defined as progression of neurological signs or symptoms, progression 
of leptomeningeal findings on MRI scan, or evidence of recurrence or progression by CSF 
cytology or tumor marker studies. 
4. 14 Adequate baseline organ function as assessed by the following laboratory values within 30 
days prior to study entry (day -30 to 0): 
Adequate renal function with estimated creatinine clearance > 50 ml/min. This will be determined 
by serum creatinine and 24- hour urine creatinine obtained concurrently. 
Adequate liver function with SGOT, SGPT and alkaline phosphatase ^ 5 times the ULN [if 
transaminases > than the upper limit of normal (ULN). Patients will have a hepatitis B surface 
antigen (HBsAG) test prior to study entry. Patients may not enter the study if HBsAG is positive. 
PT and PTT not more than 1.5 times the ULN 
Hemoglobin ^ 8.0 g/dl (patients cannot be transfusion dependent) 
Platelets >. 75,000/mm^ 
WBC > 2,000/mm3 
Absolute Neutrophil Count (ANC) ^ 1,000/mm^ 
Serum Amylase < 1.5 times the ULN 
Bilirubin < 2.5 mg/dL 
Triglyceride < 400 mg/dl 
4.15 Ability to give informed consent 
4. 1 6 Normal cardiac function by history and examination 
4.17 Resting transcutaneous oxygen saturation > 90% on room air 
4.2 Exclusion Criteria 
Patients who meet any one of the following criteria will be excluded from study entry: 
4.2 1 Pregnant or lactating females [all patients must practice adequate birth control and females 
of child-bearing potential must have a negative serum beta-HCG pregnancy test (within Day -7 to 
Day 0)]. 
4.22 Acute infection: any acute viral, bacterial, or fungal infection which requires specific 
therapy. Acute therapy must have been completed within 14 days prior to study treatment. 
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