Gene Therapy for Meningeal Carcinomatosis 
4.23 Hepatitis-B surface antigen positive patients. 
4.24 HTV-infected patients. 
4.25 Acute medical problems such as ischemic heart or lung disease that may be considered an 
unacceptable anesthetic or operative risk. 
4.26 Patients with any underlying conditions which would contraindicate therapy with study 
treatment (or allergies to reagents used in this study). 
4.27 Patients with prior ventriculo-peritoneal shunting procedure for hydrocephalus or who 
demonstrate signs, symptoms, or radiographic evidence of clinically significant hydrocephalus 
prior to treatment. 
4.3 Concomitant Medication and Treatment 
All medications or treatments will be kept to a minimum and recorded. 
4.4 Medications and Treatments Not Allowed 
Patients enrolled in the protocol will not be allowed to take any medications with 
established antitumor effects. 
4.5 Potential Risks and Discomforts Related to Evaluations 
Baseline and follow-up examinations will include blood tests, a lumbar puncture, 
aspirations of CSF from the Ommaya reservoir, and MRI scans of the brain and spinal cord. 
Risks of Blood Drawing 
Routine blood drawing may cause discomfort or temporary pain at the site of the needle 
entry may be the routine blood studies. There is remote risk of fainting and local infection. 
Risk of Lumbar puncture 
Lumbar puncture may be associated with discomfort or temporary pain at the site of the 
needle entry for the spinal tap or headaches immediately after the procedure. There is a remote risk 
of local infection, meningitis, or epidural or intradural hemorrhage. 
Risk of Ommaya Reservoir Aspiration 
Discomfort associated with tapping an Ommaya reservoir is minimal, probably less than for 
routine venipuncture. Aspiration of Ommaya reservoir for CSF may be associated with remote 
risk of infection of the hardware, ventriculitis, or obstruction of the ventricular catheter. Each of 
these may require removal or replacement of the Ommaya reservoir. 
Risks of MRI 
MRI is a painless procedure that is very safe for most patients. A small proportion of 
people develop short-lived reactions during the gadolinium administration including nausea, 
headache, hot flashes, and heart palpitations. These symptoms usually resolve spontaneously 
within minutes. Patients at risk for injury from MRI are those with pacemakers, cerebral 
aneurysm clips , or shrapnel fragments. Welders and metal workers are also at risk for injury 
because of possible metallic foreign bodies in the eye. Patients at risk for injury by MRI scanning, 
will undergo CT scanning instead. 
5 . 0 Clinical and Laboratory Evaluations 
Appendix V is the Schedule of Evaluations Table 
5.1 Screening and Baseline Evaluations 
The following clinical and laboratory evaluations will occur within Study Days -30 to 0 
unless otherwise noted. Screening evaluations, or evaluations that determine patient eligibility, are 
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