assays for viral nucleic acid in peripheral blood leukocytes (PBL) using a PCR 
technique. We also mohnitor patients at least monthly during treatment, monthly 
for the first three months following completion of treatment, every three months 
for the remainder of the year following completion of treatment, and then at 
least yearly threafter. Inaddition, we will obtain and hold frozen sera and PBL 
from each patient at each time point in the monitoring program, and hold these 
samples indefinitely. For patients with positive results in any of the above 
assays, we will attempt to identify infectious retrovirus by direct culture of 
patient PBL. For this assay, we will perform a co-culture of the patient PBL 
with a cell line susceptible to retroviral infection such as NIH3T3 cells. 
5.0 PATIENT SELECTION AND RECRUITMENT 
5.1 Eligibility: 
A total of 18 patients with cutaneous cancer lesion(s) will be enrolled in 
the preliminary study of the maximum tolerable or 'possible* dosage study. 
Additional patients with these types of cancer (meleinoma, breast cancer, and 
head and neck cancer) will be treated at the maximum toleraated dose only after 
the review of the initial experience and the approval by the IRB and the RAC. 
Fig. 6 shows the 95% confidence limits for response rate at the completion of 
treatment of 15, 25, or 35 patients. 
A. Patients must have histologically confirmed metastatic, and/or 
unresectable, locally advanced melanoma, breast cancer, or head and 
neck cancer for which curative measures do not exist or are no longer 
effective. They should have accessible cutaneous tumors. Patients 
must have expected survivals of i2. months or less. Patients must be 
off all other antitumor therapy for at least 1 month prior to 
beginning this treatment. 
B. Women of child-bearing potential must have a negative pregnancy test. 
C. Patients must have a negative HIV test. 
D. Patients must have intact cell mediated immunity as manifested by a 
positive response to any one of a broad panel of skin tests including 
TB, mumps, Candida, and SKSD (Merieux skin test) . Skin tests will be 
read at 48 hours. 
E. Patients must be free of systemic infection. 
F. Patients must have the following laboratory values: 
1. WBC > 2000/mm3 
2. Platelet count > 50,000 
3. Bilirubin < 2mg/dl 
4. Creatinine < 2mg/dl 
G. Patients must have biopsy proven metastatic melanoma, breast cancer, 
or head and neck cancer that is measurable by physical exam, or 
radiologic iimvaging after biopsies of tumor material have been 
obtained . 
H. Patients must be at least 16 years old. 
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Recombinant DNA Research, Volume 19 
