This Phase I study will be conducted exclusively at Duke University Medical Center. 
The study will enroll up to 20 patients. All patients will be evaluated for immune 
responses and survival, although not all these evaluations will be measurable end 
points. The primary end point will be evaluation of the toxicity of the treatment. A 
grade 3 or 4 will eliminate the patient from continuing on study as noted in appendix 
G. 
An additional endpoint will be the assessment of CTL responses. Peripheral blood 
mononuclear cells (PBMC) sampled both before and after product administration will 
be assayed for cytolytic activity on unmodified autologous melanoma target cells. 
CTL activities will be determined and converted to lytic units. Doubling of CTL lytic 
units above control pre-treatment levels will be considered an endpoint. Following 
enrollment of an intial 10 patients, if none attain this endpoint, there is a 95% chance 
that less than 30% of patients in this population subset will engender such a response, 
and, barring clear objective evidence of tumor regression, the protocol will be 
discontinued. If increases in CTL lytic units are observed in at least one of the initial 
10 patients, an additional 10 patients will be enrolled. This will allow for estimation 
of toxicity with a standard error of 7%. 
Survival time from the date of diagnosis of metastatic melanoma to death will be 
evaluated. Also, the time from the date of initiation of therapy on this study to death 
or 36 months, will be measured. Therapy will continue until the end of the 21 months 
for vaccinations; however, a patients will be taken off study at the time of progression 
of disease, death of the patient, or discretion of the investigator. 
4.7 TREATMENT SCHEDULE AND ON-STUDY EVALUATION: 
A. 7 -IFN Transduced autologous tumor (ITAT) dosage and schedule: 
The patients will be administered approximately 2 x 10 6 tumor cells that have 
been transduced with the 7 -IFN gene and irradiated with 10,000 RADS. 
ITAT will be administered every 2 weeks for the first 3 months. Subsequent 
boosting may be administered monthly thereafter until 24 injections have been 
administered. 
B. Immunological tests: 
a. On at least 2 occasions before treatment, 20 ml. of heparinized blood 
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