Protocol ID93-008 
Page 2 of 5 
These biopsies will be obtained to determine if the TIL have 
migrated to the tumor. This information might be useful for the 
development of future treatment strategies in -other patients with 
ovarian cancer. The laparoscopic surgery will be performed to 
evaluate the response to the treatment and not for the marker 
study alone. There is no cost to the patient for the preparation of 
the cells for the treatment or for the retrovirus marker. There is 
also no cost to the patient from special laboratory tests related to 
the conduct of this protocol. Patients will be followed indefinitely 
and if the patient happens to move, a forwarding address will be 
requested. In the unfortunate event of death, an autopsy will be 
requested from family members. Nine patients may receive 
retrovirus-modified cells in this protocol. 
4. RISKS. SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
This virus and another like it have been given to over 100 patients 
for at least the past 4 years at other institutions. No adverse 
effects were observed in these studies because the virus is modified 
so that it cannot cause an infection in the cells of the body. 
Risks, however, which may not yet have been observed, are 
possible. TTiese are “theoretical risks" since they have not yet been 
seen in patients who have received the retrovirus. It is possible 
that the virus could change the cells which are marked so as to 
grow in an abnormal pattern, and even cause cancer or leukemia. 
The gene marker might also produce a protein which might 
inactivate certain antibiotics but alternative antibiotics are 
available so that this does not constitute a risk or threat for 
patients during therapy. 
There is a small risk of bleeding from biopsy sites. 
This clinical research study may involve unforeseeable risks to the 
participant. 
5. POTENTIAL BENEFITS: There are no direct therapy benefits to the 
patient whose TIL have been marked with the gene containing the 
retrovirus. Information provided may be able to show that the TIL 
have a preferred uptake at tumor sites. 
6. ALTERNATE PROCEDURES OR TREATMENTS: The participant 
may receive the TIL in the treatment protocol without these cells 
being exposed to the retrovirus. 
UNDERSTANDING OF PARTICIPANTS 
Recombinant DNA Research, Volume 19 
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