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 9 
5.0 PLAN OF CLINICAL STUDY 13 
6.0 EVALUATION OF EFFECTS 14 
7.0 IMPACT OF OUTCOME ON SUBSEQUENT TREATMENT . . 15 
8.0 STUDY SIZE 16 
9.0 DRUG INFORMATION 18 
10.0 PATIENT ELIGIBILITY 22 
11.0 OUTLINE OF THERAPY 22 
12.0 CONCURRENT TREATMENT AND SUPPORTIVE CARE .. 26 
13.0 EVALUATION DURING THERAPY . 27 
15.0 RESPONSE CRITERIA 29 
16.0 OFF-STUDY CRITERIA 29 
17.0 RECORDS TO BE KEPT 29 
18.0 INFORMED CONSENT 30 
ASSENT FORM 36 
APPENDICES 38 
Recombinant DNA Research, Volume 14 
