Dosage 
Group 
No. of patients 
per group 
Dose per 
treatment 
Total no. of 
treatments per 
patient 
Days between 
treatments 
I 
3 
10 pg 
2 
15 
n 
3 
10 pg 
3 
15,14 
Arm 1 patients will be followed for 8 weeks with a tumor staging at that time. Arm 2 
patients will be followed for 10 weeks with a tumor staging at that time. See Appendix 
1 for the schedule of events. 
4.0 PATIENT ELIGIBILITY 
Patients will be carefully selected based on their past medical history and present 
status. The Investigator and the patient will make a joint decision regarding the 
appropriate treatment with conventional therapy. Patients will be selected who have 
failed on conventioncd therapy or for whom conventional therapy is not indicated. 
4.1 Inclusion Criteria 
4.1.1 Diagnosis : 
Histologically confirmed metastasis of malignant melanoma. 
Histologic confirmation may be by needle biopsy at the time of intratumoral 
injection. 
4.1.2 Patients must have at least one metastatic lesion measurable in two dimensions 
and at least 1 cm in longest diameter. 
4.1.3 Patients must have had either prior standard therapies for their disease and have 
become unresponsive to them or have made the decision that other therapy 
would not be of any benefit. 
4.1.4 Patients must be adults 18 years of age or older. 
4.1.5 Patients must be HLA-B7 negative. 
4.1.6 Patients must have adequate bone marrow reserve: WBC >3000/mm3, platelets 
>100,000/mm3, hemoglobin >9.0 gm% and adequate renal and liver function, 
creatinine j^2.0 and bilirubin < 2.0 mg/DL. 
4.1.7 Patients must have a baseline Kamofsky Performance Status (KPS) score of at 
least 70. (Appendix 2) 
[244] 
Recombinant DNA Research, Volume 19 
