PROTOCOL SYNOPSIS 
Title : Genetically-Engineered Autologous Tumor Vaccines Producing Interleukin-2 for the 
Treatment of Metastatic Melanoma 
Objective: 
To evaluate the safety and efficacy of administering a live, irradiated 
autologous tumor cell mixed with irradiated IL-2 producing melanoma cell 
line. 
To evaluate the immunological and clinical responses of patients receiving 
the vaccine preparation. 
PoDulation: 
Patients with metastatic melanoma 
SamDle Size: 
10 patients in 3 dose-escalation groups (total of 30 patients) 
Dosaee/Treatment: 
10 7 autologous tumor cells admixed with an allogeneic melanoma cell line 
(M24-IL-2) transduced with IL-2 gene. Sufficient numbers of M-24 IL-2 
will be added to produce 10 3 , 10 4 , or 10 5 pg/24hr according to treatment 
group. 
Duration: 
Patients will be vaccinated biweekly for 6 doses, then monthly thereafter 
for up to one year. 
Endpoints: 
Safety: local and systemic toxicity 
Efficacy: Clinical response of measurable lesions, immunological response 
to tumor cell skin tests. 
Investigators: 
James S. Economou, M.D., Ph.D. 
John A. Glaspy, M.D. 
Collaborating 
Biotechnology 
Company: 
Genetic Therapy, Inc., Gaithersburg, MD 
Recombinant DNA Research, Volume 18 
[417] 
