PROTOCOL THS 94-002 
REVISED 05/24/94 
PAGE 3 of 6 
4a. This clinical procedure may involve unforeseeable risks to unborn 
children; therefore, the participants should practice adequate methods 
of birth control throughout the period of their involvement in the 
clinical study if they are sexually active. To help prevent injury to 
children, the female participants should refrain from breast feeding 
during participation in the clinical research study. 
4b. Possibility of Causing a New Cancer. It is possible that the research 
could cause cancer in normal cells but the investigators believe the 
risk is very small particularly because the investigators test the 
material that is injected to make sure it does not contain disease- 
causing viruses. 
4c. Side Effects of Chemotherapy. The usual expected side effects of 
this treatment include nausea and vomiting, hair loss, mouth ulcers, 
skin rash, or diarrhea. Toxic effects to the bone marrow cells may 
occur, and may make a patient more susceptible to serious infections 
or bleeding. Additional side effects may include: kidney damage, 
hearing loss, nerve damage which may cause numbness or tingling. 
Since there is no experience with the adenovirus and chemotherapy 
combination and since no other patients have received this virus, 
there is a possibility of unexpected, severe, or even permanent 
damage to any body organ. All patients will be closely monitored for 
the development of complications and every attempt will be made to 
prevent them. 
5. POTENTIAL BENEFITS: The primary purposes of this study are scientific 
namely, to test the safety of the procedure and to see whether the injected 
gene will function in the cancer cells. If this happens, there might be a 
potential benefit to subjects, depending on how much of their cancer is 
destroyed. The main benefit expected is advancing knowledge and 
developing future studies and treatments rather than curing the patient- 
subjects who participate in this study, although that is always a possibility. 
6. ALTERNATE PROCEDURES OR TREATMENTS: Patients will be eligible for 
this study if conventional therapy such as surgery or external beam radiation 
therapy has already been performed or cannot be done. Alternatively 
chemotherapy alone can be given. 
UNDERSTANDING OF PARTICIPANTS 
7. I have been given an opportunity to ask any questions concerning the 
procedure involved and the investigator has been willing to reply to my 
inquiries. This procedure will be administered under the above numbered, 
titled and described clinical research protocol at this institution. I hereby 
authorize Dr. Jack A. Roth, the attending physician/investigator and 
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Recombinant DNA Research, Volume 19 
