INFORMED CONSENT 
UAB 9405 
March 16, 1994 
Informed Consent 
TITLE: Phase la Trial of a Polynucleotide Vaccine to Human Carcinoembryonic Antigen 
in Patients with Metastatic Colorectal Cancer 
INTRODUCTION AND PURPOSE 
I understand that I have metastatic cancer of the colon or rectum.. My cancer had spread outside 
the confines of the colon and is not surgically curable. I also understand that I have received 
chemotherapy with 5-fluorouracil (with or without other agents) and that my tumor has either not 
responded to therapy or relapsed after transient response. 
Investigators at the University of Alabama at Birmingham Cancer Center are currently looking 
into innovative treatments to improve the therapy of metastatic colon and rectal cancer. I have 
been asked by my physicians to participate in a research study using a form of gene therapy 
tumor vaccine in an effort to stimulate the anti-tumor potential of my immune system. 
This form of gene therapy utilizes the intramuscular injection of the gene for carcinoembryonic 
antigen (CEA), a tumor-associated antigen expressed on the surface of your colorectal cancer 
cells. It is expected that a small fraction of your muscle cells will express CEA and stimulate an 
immune response directed against your tumor cells. This form of gene therapy is called a 
polynucleotide vaccine since the gene injected into your muscle may induce an immune response 
to the CEA molecule. This polynucleotide vaccine to CEA antigen is investigational. 
This gene therapy polynucleotide vaccine has been tested in animals and found to be safe and to 
induce anti-tumor effects. This type of vaccine therapy has not been given to patients previously 
so the side effects or toxicity are unknown. This trial will evaluate the side effects as well as the 
immunologic response to this polynucleotide vaccine. 
EXPLANATION OF PROCEDURES 
The initial groups of patients 'Mil each receive increasing doses of the vaccine dependent upon a 
lack of side effects in the prior group of patients. Later in the trial, patients will receive three 
vaccinations at three-week intervals using doses that were well tolerated as single vaccinations. 
A vaccination will involve an injection of vaccine into each deltoid muscle (back of arm) using a 
syringe and needle with a volume of less than 0.5 ml (less than 1/1 0th of a teaspoon). I will be 
closely followed for any side effects. 
Patient’s Initials 
Recombinant DNA Research, Volume 19 
[417] 
