Informed Consent 
XIII. Consent Form - CONSENT TO PARTICIPATE IN A CLINICAL STUDY 
Institution: Clinical Research Branch, Biological Response Modifiers Program, 
NCI 
Study Number: T93-XXXX, BRMP 9401 
Principal Investigator: Mario Sznol, M.D. 
Study Title: A Phase I trial of B7- trans f ected lethally irradiated 
allogeneic melanoma cell lines to induce cell-mediated immunity against tumor- 
associated antigen presented by HLA-A2 or HLA-A1 in patients with stage IV 
melanoma 
Introduction 
We invite you to take part in an experimental, research study at the BRMP. It 
is important that you read and understand several general principles that 
apply to all who take part in our studies: 
(a) taking part in the study is entirely voluntary; 
(b) personal benefit may not result from taking part in the study, but 
knowledge may be gained that will benefit others; 
(c) you may withdraw from the study at any time, or refuse to participate, 
without penalty or loss of any benefits to which you are otherwise entitled. 
Your doctors have told you that standard therapies are no longer controlling 
your cancer. For this reason we are asking you to participate in this 
investigational study. The treatment that you are being offered may be 
helpful to control your disease. However, it is investigational and therefore 
it is not possible to determine the likelihood of benefit to you at this time. 
Treatment 
Scientists have recently discovered that the tumors from some patients with 
melanoma contain a protein (called an antigen) that can be recognized by the 
immune system. This means that blood cells called lymphocytes could attach 
to the tumor cells and recognize that the tumor cells are not normal and don't 
belong in the body. Once the lymphocyte determines that the tumor cells are 
not normal, it would kill them or call other blood cells to the site that 
would help eliminate the tumor cells. Although the potential for this immune 
response exists in some patients with advanced melanoma, for reasons that we 
still do not understand, the immune system has somehow been paralyzed and 
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