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I have been told that interleukin-2 administration may be associated with the following 
side-effects - tiredness, fever, chills, sweats, nausea, vomiting, shortness of breath, nasal 
congestion, confusion, seizures, low blood pressure, low urine output, heart attack, arthritis, 
vision changes, low blood counts, muscle pains, knee tenderness, infection, flu-like symptoms, 
unknown side-effects and death. Most of these side-effects are reversible within 24-48 hrs 
following discontinuation of IL-2 and are partially minimized by certain medications. 
I have been told that interferonaA (IFNaA) administration may be associated with the 
following side-effects: flu-like symptoms, fever, chills, fatigue, muscle pain, headache, loss of 
appetite, nausea, vomiting, diarrhea, dizziness, rash, itchy skin, weight loss, partial hair loss, 
decreased mental alertness, visual disturbances, worsening of heart condition, such as high blood 
pressure, chest pain, irregular heart beat and death. Most are reversible and partially minimized 
by certain medications. IFNaA is approved by the FDA for hairy cell leukemia and renal cell 
carcinoma. 
I have been told that TIL and/or PBL administration may be associated with side-effects 
consisting of fever, chills, and some shortness of breath. Based on past experience, these are 
expected to last only a few hours. 
I have been told that the risks of placing catheters for intravenous infusions include 
infection, bleeding, collapsed lung and clotting of blood vessel. 
Drawing of blood by vein may be associated with the complications of swelling, pain, 
bruising, fainting, and rarely inflammation or infection. Blood draws will be performed twice 
weekly (20 ml, 1/12 cup). 
If l am of child-bearing potential, I will not participate in this research protocol unless, 
with the investigator’s knowledge and approval, I am employing a medically acceptable form of 
birth control (contraception). This research may have unforeseeable risks to an embryo or fetus. 
A pregnancy screening test will be performed at no cost to me and a negative result will be 
required prior to the initiation of therapy. 
5. Potential benefits : This experimental treatment will be expected, on the basis of past 
experience, to cause partial or complete regression of tumor in some patients. I understand that 
there may be no direct benefi t to me from study participation, and there is a possibility my 
condition mayjbecome worse. 
6. Alternate procedures or treatment : This experimental clinical protocol is offered to me 
because my^ cancer is advanced and conventional methods of therapy - surgery, chemotherapy 
and/or radiation therapy - have not proven beneficial. 
HSPC #91-10-442 
Date of expiration 
[556] 
Recombinant DNA Research, Volume 15 
