Gene Therapy for Meningeal Carcinomatosis 
TABLE OF CONTENTS 
ABSTRACT 
1.0 BACKGROUND AND RATIONALE 
1.1 Disease Background/Current Treatment 
1 .2 Strategy of Gene Therapy 
1.3 Description of Viral Vector 
A ppendix I is the vector construct 
1 .4 Preclinical 
1.41 Efficacy studies 
1.42 Toxicity studies 
A ppendix II is pre-clinical efficacy and toxicity data 
A ppendix III is Figures of preclinical data 
A ppendix IV is Tables of preclinical data and study design 
1.5 Clinical 
1.6 Objectives 
2.0 STUDY DESIGN 
2.1 Overview 
2.2 Number of Patients/Participating Sites 
2.3 Patient Management/Special Facilities 
2.4 Study Duration 
3.0 STUDY TREATMENT 
3.1 Method of Administration 
3.2 Dosing Regimen 
3.3 Risks, Hazards, and Discomforts 
4.0 PATIENT SELECTION 
4.1 Inclusion Criteria 
4.2 Exclusion Criteria 
4.3 Concomitant Medicauon and Treatment 
4.4 Medications and Treatments Not Allowed 
4.5 Potential Risks and Discomforts Related to Evaluations 
5.0 CLINICAL AND LABORATORY EVALUATIONS 
5.1 Screening and Baseline Evaluations 
5.2 Interval Evaluations 
5.3 Post-Treatment Evaluations 
5.4 Considerations/Evaluations Upon Premature Withdrawal 
A ppendix V is schedule of evaluation 
6.0 TREATMENT MODIFICATION AND DISCONTINUATION 
ACCORDING TO LEVEL OF TOXICITY 
6.1 Treatment Modification and General Management of Toxicides 
6.1 1 Management of Specific Toxicides 
6.2 Symptomatic Therapy for Toxicity 
A ppendix VI is the Toxicity Grading Table 
Recombinant DNA Research, Volume 18 
