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3. Description of research protocol : I underst a nd that the immune lymphocytes or white blood 
cells to be used in this experimental treatment will come from two sources - blood and tumor. 
Immune lymphocytes from my blood (also called peripheral blood lymphocytes, PBL) will 
require that 40 ml (1/6 cup) of blood be removed by needle puncture of a vein. Tumor immune 
lymphocytes (also called tumor-infiltrating lymphocytes, TIL) are isolated from a resected portion 
of my tumor. I understand that PBL and TIL are then placed in culture flasks where they are 
grown in an incubator for 4-6 weeks. In order for these PBL and TIL to grow to large numbers 
(from 1,000,000,000 to 100,000,000,000), a growth factor is added to the culture flasks. This 
growth factor is called interleukin-2 (IL-2) and has the additional property of making these 
lymphocytes more effective tumor-killing lymphocytes. After these PBL and TIL are grown to 
sufficiently large numbers, they are reinfiised by vein back to me , I will then be given IL-2 and 
i nterfer onaA. IL-2 helps the PBL and TIL grow and function in me. to addition, IL-2 has anti- 
cancer properties by itself. Interferon-aA (IFNa) is given because it has anticancer properties 
as well and is approved for the treatment of hairy cell leukemia and renal cell cancer. IL-2 is 
given by continuous infusion by vein 4 days out of 7 for up to 64 days of treatment in a 22 week 
period. IFNaA is given by injection under the skin 2 days out of 7 for up to 32 days of 
treatment in a 22 week period. During treatment, biopsies of tumor and adjacent skin, fat and 
muscle and blood draws (10 cc, 1/24 cup) may be requested one or more times. I have seen and 
u nderstand the schedule of tre atments on page 6. I may refuse these purely investigational 
procedures at any time without prejudice. I will need to be seen weekly for up to 22 weeks and 
monthly thereafter. 
I will be randomly assigned to receive one of the following 4 combinations of immune 
lymphocytes: (A) TIL and PBL, (B) CD8 (suppressor) TIL and CD8 (suppressor) PBL, (C) 
CD4 (helper) TIL and CD4 (helper) PBL, or (D) CD8 (suppressor) TIL and CD4 (helper) TIL. 
I under stand that both suppressor and helper lymphocytes are found in tumors and peripheral 
blood and in animal tumor models, both have anticancer activity. 1 have b een told that it is not 
known whether one or more of these cell types in humans have better anticancer activity than 
the others. I under stand that one goal of this study is to see if these immune lymphocytes have 
different anticancer properties. 
4. Risks . 
I know that at least one surgical operation 
will be required to remove enough tumor for the production of TIL for this experimental therapy. 
After treatment begins, a request to remove one or more portions of additional tumor may be 
made. These post-treatment biopsies may include tumor and adjacent skin, fat and muscle and 
are for research analysis only and of no direct benefit to me. These biopsies would be requested 
only for tumors directly beneath the skin. I_will receive separate, detailed, surgical informed 
consents for all operative procedures and may refuse at any time without prejudice. I know that 
the risks of the entry surgical procedure will depend on the anatomic site of the tumor and will 
be discussed by the attending surgeon. Post-treatment biopsies are considered minor procedures 
but are associated with some local pain, and possibly minor wound problems. 
HSPC #91-10-442 
Date of expiration 
Recombinant DNA Research, Volume 15 
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