Title: Phase I Study of Advanced Colorectal Carcinoma by Direct Gene Therapy into 
Hepatic Metastases 
Participants: Joseph Rubin, MD, J. William Charboneau, MD Carl Reading, MD, 
John S. Kovach, MD 
PATIENT CONSENT FORM 
FEDERAL REGULATIONS REQUIRE WRITTEN INFORMED CONSENT FROM 
PARTICIPANTS PRIOR TO PARTICIPATION IN A RESEARCH STUDY SO THAT 
THEY CAN KNOW THE NATURE AND RISKS OF PARTICIPATION AND CAN 
DECIDE TO PARTICIPATE OR NOT TO PARTICIPATE IN A FREE AND INFORMED 
MANNER. YOU ARE ASKED TO READ THE FOLLOWING MATERIAL TO ENSURE 
THAT YOU ARE INFORMED OF THE NATURE OF THIS RESEARCH STUDY AND 
OF HOW YOU WILL PARTICIPATE IN IT IF YOU CONSENT TO DO SO. SIGNING 
THIS FORM WILL INDICATE THAT YOU HAVE BEEN SO INFORMED AND THAT 
YOU GIVE YOUR CONSENT. 
The purpose of this study is to determine the safety and optimal dose of a DNA 
(deoxyribonucleic acid)/liposome compound when injected directly into colorectal 
cancers which have spread to the liver. The DNA /liposome complex contains a human 
gene (referred to as HLA-B7) which is known to enhance rejection of foreign cells by the 
immune system in individuals who do not carry this gene naturally. The goal of this 
study is to transfer this gene to the cancer cells in the liver, thereby making them (and 
possibly any malignant cells elsewhere in the body) susceptible to destruction by the 
normal immune cells (cytotoxic lymphocytes) of the patient. The chance of benefit from 
this experimental therapy cannot be predicted. 
Participants in this study will be admitted to the General Clinical Research Center 
(GCRC) at Saint Marys Hospital. Up to four direct injections of the DNA/liposome 
complex into a single liver tumor will be performed in the Diagnostic Radiology 
Department at Saint Marys Hospital using an ultrasound technique to directly visualize 
the tumor. A biopsy of the tumor will be obtained immediately prior to the first 
injection. The injections will be made under sterile conditions after providing a local 
anesthetic (xylocaine), and multiple areas within a single nodule will be injected up to 4 
times. The duration of this procedure is usually 30 minutes. Participants will be 
observed for 24-48 hours in the GCRC following the injection. Biopsies of the liver 
nodule will be repeated at Saint Marys Hospital two weeks and four weeks after 
injection of the tumor. If there is evidence that the tumor is shrinking four weeks 
following injection, the participant may receive one or two additional injections into the 
liver at 4-week intervals. These additional injections will be considered on a case-by- 
case basis only, following consultation with the patient-subject, physician-researchers, 
and the sponsor. If uninjected tumor nodules elsewhere in the body also shrink, a 
needle biopsy of these tumors may also be done to study the mechanism of tumor 
destruction. Blood samples for research purposes will be obtained prior to tumor 
injection at 1, 2, 4, 8 weeks, then every 3 months for 1 year. The total volume of blood 
drawn for research purposes will be less than 500 mL (one pint). 
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Recombinant DNA Research, Volume 18 
