7.2 Patients will be admitted to the University of Illinois Hospital the 
morning of the administration of the IL-2-secreting cells. Patients will 
remain in the hospital for 23 hours following each immunization. 
7.3 A series of four courses of immunization will be administered 
intramuscularly and intradermally into either the thigh or the arm of the 
patient. The sites will vary with each immunization. A limb that has 
undergone a lymph node dissection will not be used for the injection site. 
One course of therapy will consist of four (4) immunizations administered 
every three weeks. Thus, the last of the four injections in a course will be 
administered at week 9. 
If a patient develops a significant titer of anti melanoma antibody without 
evidence of disease progression or has a clinical response (section 10.0), 
four additional courses will be given over a period of one year. 
Blood tests will be performed prior to each immunization (see section 8.0 and 
addenda) . 
7.4 If a patient develops a severe reaction to the vaccine, defined as grade 4 
toxicity (see section 11.0), or deteriorating performance status necessitating 
hospitalization, subsequent immunizations will not be administered. 
7.5 Criteria for removal from study: 
7.5.1 Progression of disease (section 10.0). Appearance of small (< 2 
cm diameter) superficial cutaneous or subcutaneous metastases prior to week 9 
will not be considered disease progression. 
7.5.2 Severe intercurrent illness. 
7.5.3 Recurrence of any grade 3 toxicity. 
7.5.4 Any grade 4 toxicity. 
7.5.5 General or specific alteration in the patient's condition which 
would render further treatment unacceptable in the judgment of the principal 
investigator . 
7.6 Formulation of immunogen: The established melanoma cell-line was 
transduced with the retrovirus pZipNeoSVIL-2 (Dr. Cohen) . After primary 
selection (G418), the secretion and quantitation of human IL-2 for both X- 
irradiated (5000 rads) and non irradiated cells was confirmed. No cells 
subjected to X-irradiation survived. Aliquots of the suspension of IL-2- 
secreting allogeneic cells are stored in liquid nitrogen (Dr. Cohen). 
9 
Immediately before immunization, vials containing approximately 10 cells will 
be thawed, washed, counted and subjected to 5000 rads X-irradiation. 
Afterwards, the cells will be delivered to the Surgical Oncology Clinic for 
intramuscular and intradermal injections into tumor-bearing melanoma patients 
by the principal investigator. The frozen cells will have been found to be 
free of recombinant helper virus, myoplasma, bacteria, fungi and other 
adventicious agents. 
Recombinant DNA Research, Volume 18 
