• • 
"V. 
. MfDjCAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
INSTITUTE- NATIONAL CANCER INSTITUTE 
STUDY NUMBER 
86-C-183 S.A. Rosenberg, M.D., Ph.D 
PRINCIPAL INVESTIGATOR: 
STUDY TriL==- Treatment Of Patients With Advanced Cancer Using High Dose Recombinant 
Interleukin- 
-2 Plus Cyclophosphamide And Tumor Infiltrating Lymphocytes 
1 — _ 
* ■ 
INTHODUCTICN 
We Invite you (or your child) to take part in a research study at the National Institutes'of Health. It is important that you 
read and understand several general principles that apply to all who take part in our studies: (a) taking part in the study 
is entirely voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained tha: 
will benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you 
are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information 
about the study are discussed below. You are urged to discuss any questions you have about this study with the staff 
members who explain it to you. , " , , , r 
Your disease has spread to portions of your body such that conventional methods of therapy 
as drugs, surgery and radiotherapy are no longer beneficial. Treatments are being ofiered t 
you may helo your disease although these are experimental treatments and it is not posoible 
.to determine any benefit. • . ' ' 
You will receive a single intravenous injection of a chemotherapy drug called cyclophos- 
phamide. This drug may cause side effects including nausea and vomiting, decrease in blood ^ 
counts, an increased susceptibility to infections, bladder problems (including bleeding) and 
hair loss. 
I Twenty-four to' forty-eight hours later you will receive the. administration of a substance 
‘ called interleukin-2 (IL-2) into your bloodstream. Interleukin-2 is a biological' substance 
|j normally produced by the body in small amounts. Using new biotechnology techniques t ® 
! interleukin-2 can be produced in large amounts in bacteria. This substance has been purifie 
and will be injected into your bloodstream every eight^hours for about six days. 
The administration of the interleukin-2 that you will receive can cause side effects which 
include weight gain which can reach as much as 20 lbs of fluid over the course o seve.a 
i weeks. This weight gain results in swelling in your extremities and can result in acc^ulat 
i of fluid in the lungs. This can cause shortness of breath and require placement of a tube l 
your trachea for mechanical breathing. Shortness of breath is common and you may . 
oxygen during some portion of this treatment. Other side effects include fever an c. .s 
which generally can be eliminated by the use of appropriate medications. You also 
develop nausea, diarrhea, a skin reaction with itching, nasal congestion, and a norma t es 
in kidney and liver function. You also may develop mental changes_ ranging from confusion ar 
forgetfulness to disorientation. Other possible side_ effects include feelings o ^ ness 
: and dry mouth. It also is possible that your blood counts may drop and that you might requ; 
j CONSENT TO PARTICIPATE IN A CLINICAL 
Recombinant DNA Research, Volume 14 [19] 
