Table of Contents 
Page 
Scientific Abstract i 
Non-Technical Abstract ji 
Institutional Biosafety Committee Approval iii 
Institutional Review Board Approval iv 
Points to Consider 1-5 
Clinical Protocol 
1.0 Objectives 1 
2.0 Background/Rationale 1 
2. 1 Interleukin-2 Cancer Immunotherapy in Human Subjects 
2.2 Cytokine Gene Therapy in Animal Tumor Models 
2.3 Immunotherapy of Human Colon Cancer 
2.4 Gene Transfer into Human Subjects 
3.0 Treatment Schema 3 
4.0 Patient Selection and Registration 5 
4. 1 Eligibility 
4.2 Registration 
5.0 Therapeutic Modalities 6 
5. 1 Preparation and Characterization of Biological Agents 
5.2 Potential Toxicity 
5.3 Treatment of Toxicity/Supportive Care 
6.0 Therapy Plan 8 
6. 1 Location 
6.2 Administration of Biological Agents 
7.0 Therapy Modification 8 
7.1 Dose Escalation 
7.2 Maximum Tolerated Dose 
Recombinant DNA Research, Volume 18 
[631] 
