Gene Therapy for Meningeal Carcinomatosis 
TABLE OF CONTENTS (CONT.) 
7.0 CRITERIA FOR DISCONTINUATION OF STUDY PATIENTS 
7.1 Criteria for Treatment Discontinuation 
7.2 Criteria for Study Discontinuation 
8.0 ADVERSE EXPERIENCES 
Appendix VII is Adverse Experience Reporting 
9.0 EVALUATION OF RESPONSE/ENDPOINTS 
9.1 Required Documentation 
A ppendix VIII is Evaluation of Response 
10.0 DOCUMENTATION, RECORD KEEPING, CRFs 
11.0 DATA COLLECTION AND STUDY MONITORING 
A ppendix IX is processing of tissue samples 
12.0 BIOSTATISTICAL CONSIDERATIONS 
13.0 ETHICAL CONSIDERATIONS 
13.1 Informed Consent 
13.11 - Phase A 
13.12 - Phase B 
13.13 - Phase C 
13.14- Phase D 
Appendix X is the Patient Informed Consent 
1 3 .2 Padent Confidendality 
13.3 Patient’s Financial Responsibilities During the Study 
14.0 CRITERIA AND PROCEDURES FOR PROTOCOL MODIFICATION 
AND STUDY TERMINATION 
15.0 PUBLICATION OF DATA/PROTECTION OF COMPANY TRADE SECRETS 
16.0 REFERENCES 
APPENDICES : 
I VECTOR CONSTRUCT AND RESTRICTION MAP 
II PRE-CLINICAL EFFICACY AND SAFETY DATA 
III FIGURES FOR PRE-CLINICAL DATA 
IV TABLES FOR PRE-CLINICAL DATA AND STUDY DESIGN 
V SCHEDULE OF EVALUATIONS 
VI TOXICITY GRADING TABLE 
VII ADVERSE EXPERIENCES REPORTING 
VIII EVALUATION OF EFFICACY 
IX INFORMATION ON PROCESSING AND STORAGE OF STUDY MATERIALS 
X PATIENT INFORMED CONSENT 
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