COMPREHENSIVE CANCER CENTER 
UNIVERSITY OF ALABAMA AT BIRMINGHAM 
BIRMINGHAM, ALABAMA 
Protocol 
PROTOCOL:UAB 9405 - Phase la Trial of a Polynucleotide Vaccine to Human Carcinoembryonic 
Antigen in Patients with Metastatic Colorectal Cancer. 
TABLE OF CONTENTS 
1.0 SPECIFIC AIMS 
2.0 BACKGROUND AND RATIONALE 
3.0 SCHEMA 
4.0 PATIENT SELECTION CRITERIA 
5.0 DRUG INFORMATION 
6.0 TREATMENT PLAN 
7.0 THERAPY MODIFICATION 
8.0 STUDY PARAMETERS 
9.0 EVALUATION CRITERIA 
10.0 PATIENT REGISTRATION 
1 1 .0 STATISTICAL CONSIDERATIONS 
APPENDICES 
A. BIBLIOGRAPHY 
B. TOXICITY CRITERIA 
C. PERFORMANCE STATUS CRITERIA 
D. ADVERSE REACTION REPORTING 
E. SPECIFIC METHODS FOR HUMORAL AND CELLULAR 
IMMUNITY TO CEA 
Approval Dates 
CSRC IRB 
David T. Curiel. M.D. 
Principal Investigator 
NCI (Pending) 
Study Sponsor 
Albert F. LoBuglio, M.D. 
Robert M. Conrv. M.D. Polynucleotide Vaccine for CEA 
Co-Investigators Study Agent(s) 
Data Coordinator 
ADDITIONAL SITES: BVAH - YES / NO AFFILIATES - YES / NO 
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Recombinant DNA Research, Volume 19 
