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PROTOCOL ABSTRACT 
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Protocol: (Give number and abbreviated title) (Two lines not to exceed 75 characters per line) 
Use of a retroviral vector to study the trafficking patterns of purified ovarian TIL populations used in 
intraperitoneal adoptive immunotherpy of ovarian cancer patients - a pilot study 
Study Chairman: 
RALPH S. FREEDMAN. M.D., Ph.D. 
Patient Eligibility: 
(Twenty lines not to exceed 75 characters per line) 
JT) Patients who participate in this protocol must also be registered on the treatment protocol 
ID92> 015 (T92-0093). 
(2) Patients with histologically documented ovarian carcinoma or peritoneal carcinomatosis who have 
persistent or recurrent disease after at least one platinum based chemotherapy and less than 2 cm 
residual. 
(3) Accessible tissue samples for TIL preparation. 
(4) Easily measurable disease preferred but not essential 
(5) Age 16 years +. 
(6) ECOG PS 0-1 Kamofsky 100-70%. 
(7) Adequate organ functions, (a) AGC > 1500/cu mm; platelets > 100.000 cu/mm; (b) Bilirubin <1.5 
mg/dl, creatinine <_1.5 mg/dl, or creatinine clearcince > 60 ml/min. 
(8) No significant hecut disease. 
(9) Adequate pulmonary reserve. 
(10) No active Infection. 
(11) No contraindication to pressors. 
(12) At least 4 weeks after chemo hormones or RT. 
(13) Negative HIV and HBg Ags. 
(14) Signed informed consent. 
Exclusions; 
(1) Intestinal dysfunction or uncorrectable obstruction. 
(2) Prior abdominal irradiation (pelvic or small treatment field may not exclude). 
(3) Extreme adhesions preventing free flow of fluid. 
(4) Prior therapy with I.P. lL-2. 
(5) Prior I.P. chemotherapy unless free of extensive adhesions. 
(6) Contraindication to surgical exploration. 
(7) ) Patients with orgein allografts and those requiring corticosteroids for intercurrent disease. 
(8) Other malignancy <10 years in remission, other than basal or squamous cell cancer of the skin. 
(9) Slgnificemt medlcal/psychlatric disorders. 
Treatment Plan: (Include dose adjustment) 
(Twenty lines not to exceed 75 characters per line) 
All paUents will be registered at the Department of Gynecology Protocol Office (713)- 792-6828. TIL will be 
obtained from tumor biopsies or abdominal cavity irrigations obtained at tumor reductive surgery or 
laparoscopy performed for the evaluation of response to prior chemotherapy or for surgical 
Tll^derived T cells will be cultured in rIL-2 supplemented medium. During the culture phase, ^ 
be purified by positive selection and an aliquot of these cells infected with a retroviral vector containing 
gene for neomycin resistance (GlNa). Purified rIL-2 expanded CD3'''CD8+ TIL ^ 
nontransduced cells) will be administered I.P. over 30 - 60 minutes with 0.033 mg ( x U) _rt/^2 will 
300 - 500 ml D5 1 /4 normal saline plus 0. 1% human albumin USP. rll^2 alone at a ^ 
be given I.P. as a bolus on days 2-4. 8-11, and 15-18. Laparoscopy will be performed in patients who have no 
clinical or radiologic evidence of disease 1 month after receiving the IP injected cells. 
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j 
Recombinant DNA Research, Volume 19 
[457] 
