18.0 CONSENT DOCUMENT 
/ / : Approval 
Biomedical IRB 
University of Pittsburgh 
Page 1 
CONSENT TO ACT AS A SUBJECT IN AN EXPERIMENTAL STUDY 
TITLE : Gene Therapy of Cancer: A Pilot Study of IL-4 Gene -Modified Tumor 
Vaccines (92-41) 
INVESTIGATORS : Michael T. Lotze, M.D. 
Director of Surgical Oncology 
Pittsburgh Cancer Institute 
Professor of Surgery 
University of Pittsburgh 
School of Medicine 
Pittsburgh, PA 15261 
(412) 648-9489 
Joshua T. Rubin, M.D. 
Assistant Professor of Surgery 
University of Pittsburgh 
School of Medicine 
Pittsburgh PA 15261 
(412) 648-9489 
DESCRIPTION : 
I have been invited to participate in a study to evaluate the benefit of 
receiving a vaccine made from my own tumor cells and skin. I am aware that my 
tumor has spread beyond the limits that are curable by surgery or other standard 
treatments. While it is not possible to predict whether I will derive any 
personal benefit from my participation in this study, information may be derived 
that will be helpful to others with similar disease. 
Before beginning treatment, my physician will perform a history and physical 
examination. I will have blood tests (approximately 6 tablespoons of blood will 
be drawn), a urinalysis, a chest x-ray, an electrocardiogram, and CT or MRI scans 
performed. Blood will be drawn on days 0 (pre- treatment) , 7, 14, 21 and 28. 
I understand that in order to prepare the vaccine, one or several tumors must 
have been surgically removed from my body during prior therapeutic or diagnostic 
procedures . This will be performed under local anesthesia if the tumors are very 
accessible, such as those lying in or just under the skin. If no such tumor is 
available, I may be required to undergo removal of tumor from my lung. This will 
be performed under general anesthesia by inserting a small tube called a 
thoracoscope into my chest through a small incision. One or 2 additional tubes 
may be inserted so that a biopsy can be performed without making a large incision 
Recombinant DNA Research, Volume 16 
[515] 
