A PILOT STUDY OF IMMUNIZATION WITH HLA-A2 
MATCHED ALLOGENEIC MELANOMA CELLS THAT 
SECRETE INTERLEUKIN-2 IN PATIENTS WITH 
METASTATIC MELANOMA 
1.0 OBJECTIVES 
2.0 BACKGROUND AND RATIONALE 
3.0 CRITERIA FOR PATIENT ELIGIBILITY 
4.0 EXCLUSION CRITERIA 
5.0 CONCURRENT THERAPY 
6.0 PRETREATMENT EVALUATION 
7.0 TREATMENT PLAN 
8.0 EVALUATION DURING STUDY 
9.0 EVALUATION OF IMMUNE RESPONSE 
10.0 CRITERIA FOR THERAPEUTIC RESPONSE 
11.0 CRITERIA FOR TOXICITY 
12.0 ADVERSE EFFECTS AND RISKS 
13.0 BIOST ATISTIC AL CONSIDERATIONS 
14.0 CONSENT PROCEDURES 
15.0 REFERENCES 
APPENDIX A INFORMED CONSENT 
APPENDIX B KARNOFSKY PERFORMANCE STATUS 
APPENDIX C STRUCTURE OF RETROVIRAL VECTOR, NAPAD/IL2 
APPENDIX D INTERLEUKIN-2 cDNA GENE SEQUENCE 
APPENDIX E VACCINE PREPARATION 
APPENDIX F RETROVIRAL VECTOR TITRATION PROCEDURE 
APPENDIX G REPLICATION COMPETENT RETROVIRUS DETECTION ASSAY 
APPENDIX H TRANSDUCTION FLOW SHEET 
APPENDIX I POST-TREATMENT LABORATORY VALUES 
APPENDIX J POST-TREATMENT IMMUNOLOGICAL VALUES 
APPENDIX K POST TREATMENT SAFETY STUDIES 
APPENDIX L EXPERIMENTAL DATA 
APPENDIX M COMMON TOXICITY CRITERIA 
APPENDIX N POINTS TO CONSIDER 
PRINCIPAL INVESTIGATORS: BERND GANSBACHER, MD 
CO-PRINCIPAL INVESTIGATORS: ALAN HOUGHTON, MD 
PHILIP LIVINGSTON, MD 
CO-INVESTIGATORS: LORI MINASIAN, MD 
Recombinant DNA Research, Volume 15 
