TABLE OF CONTENTS 
Page 
1.0 OBJECTIVES 3 
2.0 BACKGROUND 3 
3.0 RATIONAL FOR CURRENT PROPOSAL 6 
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 12 
8.0 STUDY SIZE 13 
9.0 DRUG INFORMATION 14 
10.0 PATIENT ELIGIBILITY 15 
11.0 OUTLINE OF THERAPY 16 
12.0 CONCURRENT TREATMENT AND SUPPORTIVE CARE 17 
13.0 EVALUATION DURING STUDY 20 
14.0 TOXICITY MONITORING 21 
15.0 RECORDS TO BE KEPT 21 
16.0 INFORMED CONSENT 22 
INFORMED CONSENT FORM 23 
SUMMARY STATEMENT , 27 
ASSENT FORM 30 
APPENDICES 32 
REFERENCES 46 
February 25, 1991 
vpg(wpc) 
Recombinant DNA Research, Volume 14 
[675] 
