TABLE OF CONTENTS 
Page 
1.0 OBJECTIVES 3 
2.0 BACKGROUND 3 
3.0 RATIONAL FOR CURRENT PROPOSAL 5 
4.0 STUDY OUTLINE AND SAFETY 7 
5.0 PLAN OF CLINICAL STUDY 11 
6.0 EVALUATION OF EFFECTS 11 
7.0 IMPACT OF OUTCOME ON SUBSEQUENT TREATMENT 13 
8.0 STUDY SIZE 14 
9.0 DRUG INFORMATION 15 
10.0 PATIENT ELIGIBILITY 16 
11.0 OUTLINE OF THERAPY 17 
12.0 CONCURRENT TREATMENT AND SUPPORTIVE CARE 18 
13.0 EVALUATION DURING THERAPY 21 
14.0 TOXICITY MONITORING 22 
15.0 RECORDS TO BE KEPT 22 
16.0 INFORMED CONSENT 22 
17.0 INFORMED CONSENT 24 
APPENDICES 28 
February 25, 1991 
vpg(wpc) 
Recombinant DNA Research, Volume 14 
[709] 
