delivery of treatment, or would preclude obtaining voluntary 
informed consent. 
8. Patients receiving any other concurrent investigational treatment, 
or any other concurrent treatment for their cancer. 
9. A diagnosis of a second malignancy within the past 5 years except 
carcinoma in situ of the cervix or basal cell carcinoma. 
10. Patients that are allergic to penicillin or streptomycin. 
V. Study Design 
1. Patients will be stratified by expression of HLA-A1 versus expression of 
HLA-A2 or HLA-A1/A2 . Dose escalation and accrual will proceed independently 
for these two groups. HLA-A2 patients will be treated every 2 weeks x 3, then 
monthly using one cell line at a time in the following order: DM150/B7-8, 
DM13/B7-7, and DM93/B7-3. Patients in the HLA-A1 group will receive treatment 
in the same schedule but only the DM150/B7-8 cell line will be used. A total 
of 6 vaccine administrations are allowed. Cohorts of 6 patients each will be 
accrued consecutively. The number of cells tc be injected per vaccination in 
( 
each successive cohort will be: 
Cohort A1 -1 and A2-1 - 10^ 
Cohort Al-2 and A2-2 - 10® 
Cohort Al-3 and A2-3 - 10^ 
Cohort Al-4 and A2-4 - 'MTD' of a-c with non- trans fected parental cell line 
At the 'MTD' or highest cell dose, a separate cohort of 6 patients (Cohort Al- 
4 and A2-4) will receive the same dose of the non-trans fected parental 
melanoma cell line(s). This will allow some comparison to be made as to 
whether transfection of B7 altered the immune response and toxicity to the 
tumor cells. If ongoing monitoring of these patients reveals evidence that the 
immune response was suboptimal (the definition for suboptimal response cannot 
be given until data are available from the cohorts receiving the B7 
transfected cells), then one month after the 6th injection (see below), the 
patients will be eligible to restart the treatment program with B7 transfected 
cells, presuming they would otherwise meet the eligibility criteria for the 
protocol and have had stable or slowly progressive disease. Patients with 
tumor response but a 'suboptimal' immune response to non-trans fected cells 
would continue to receive the non-transfected cells as outlined below. 
No systemic toxicity is expected with administration of either the transfected 
or non-transfected cell line. This is based on a very large experience with 
the administration of allogeneic cell lines in melanoma patients (1,12). 
Recombinant DNA Research, Volume 18 
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