TABLE OF CONTENTS 
1. TITLE 1-4 
2. PROTOCOL SUMMARY 5 
3. OBJECTIVES 6 
4. BACKGROUND 6-9 
5. CONDUCT OF STUDY 9 
5.1 Overall Design and Control Methods 9-11 
5.2 Number of patients 11 
5.3 Screening 12 
5.4 Withdrawal from Study 12 
5.5 Criteria for Replacing a Study Subject 13 
6. STUDY POPULATION 13 
6.1 Inclusion Criteria 13-14 
6.2 Exclusion Criteria 14 
7. STUDY MEDICATION DESCRIPTION 15 
7.1 Interleukin-2 15 
7.2 Interferons A 15 
7.3 Autologous CD8( + ) and CD4(+)Lymphocytes 16 
8. DEVICE DESCRIPTION 16 
8.1 AIS CELLector™ CD8 and CD4 Cell Culture Flask 16 
9. ADMINISTRATION AND DOSAGE 16 
9.1 Administration of rIL-2 16 
9.2 Administration of Interferons A 17 
9.3 Administration of CD8 ( + ) and CD4( + ) TIL and PBL 17-18 
10. TREATMENT OF SIDE EFFECTS AND TOXICITY MANAGEMENT 18 
10.1 Recombinant Interleukin-2 Toxicity 18 
10.2 Treatment of Possible Toxicity and Side Effects of 
Interleukin-2 18 
10.3 InterferonsA Toxicity 19 
10.4 Treatment of Possible Toxicity and Side Effects of 
InterferonsA 19-20 
10.5 TIL Toxicity 20-21 
10.6 Treatment of Possible Toxicity and Side Effects of 
TIL 21 
Recombinant DNA Research, Volume 15 
[513] 
