Protocol ID93-008 
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THE UNIVERSITY OF TEXAS 
M.D. ANDERSON Informed Consefit 
CANCER CENTER 
PROTOCOL TITLE: Use of a retroviral vector to study the trafficking 
patterns of purified ovarian tumor infiltrating lymphocytes (TIL) used in 
intraperitoneal adoptive immunotherapy of ovarian cancer patients. A 
pilot study 
L 
Participant’s Name I.D. Number 
You have the right to know about the procedures that are to be used in 
your participation in clinical research so as to afford you an opportunity 
to make the decision whether or not to undergo the procedure after 
knowing the risks and hazards involved. This disclosure is not meant to 
frighten or alarm you; it is simply an effort to make you better informed 
so you may give or withhold your consent to participate in clinical 
research. This informed consent does not supersede other informed 
consents you may have signed in other protocols. 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF STUDY: This is a clinical research study to 
determine whether lymphocytes (white blood cells) that are 
cultured from a patient’s tumor, migrate back to the tumor after 
injection. Patients who participate in this marker study must also 
be participants in the companion therapy trial (ID92-015). 
3. DESCRIPTION OF RESEARCH: Lymphocytes that are obtained 
from tumors are called tumor infiltrating lymphocytes or TIL. 
These TIL are grown in culture together with interleukin-2 before 
being administered intraperitoneally to patients in the 
accompanying therapy protocol ID92-015. Patients whose TIL 
could not be grown in culture and those with medical immunologic 
disorders which would make them unsuited for treatment, are 
excluded from the trial. During the growth of the TIL in culture a 
bacterial “marker" gene will be inserted into the TIL using a 
defective mouse retrovirus so that they can be traced after 
reinjection into the patient. Samples of blood (about 10 cc each) 
and peritoneal fluids (approximately 100 cc) will be obtained from 
the patient for treatment with TIL and on days 4, 11, 18 and at one 
month after receiving the TIL injection. One month after receiving 
the TIL, patient’s will undergo a laparoscopy to evaluate their 
responses to the treatment. At this time biopsies will be obtained 
from tissues suspected of being involved with cancer. Biopsies will 
also be obtained from certain normal tissues, e.g., peritoneum 
(lining of abdominal cavity) and lymph node (if easily accessible). 
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Recombinant DNA Research, Volume 19 
