-■■■fee- 24-’ 94 THU 14:38 I D: HEhflTOLOGY-ONCOLOGY FAX ND: 602-626-2225 
0444 P05 
SUBJECTS’ CONSENT FORM 
TITLE; Phase I Srudy of Immunotherapy 
of Malignant Melanoma by 
Direct Gene Transfer 
Page _2_of.5_ 
Appr. Date: 11/23/53 
Rev: 1/13/94 
Numben 
SWOG; 
KSC: 93-175 
lest, other HIV test, special other blood tests and my tumor sites will be measured, 
either by direct measurement or x-ray measurement. 
If I agree to partidpate, I will be asked to agree to the following which is described 
below.: 
If I dedde to taj;e part in this study, I will receive my injections as an outpatient. 
In this study, injections of manufactured genes will be offered that may help to fight 
this disease in other patients. Because this treatment Is e.xpe.dmental, I may not 
derive an> direct benefit from it. The purpose of this study is to determine a safe dose 
of a new treatment which will attempt to induce tumor shrinkage. Because this is 
new and experimental, I will be observed to determine the side effects of the therapy. 
I will also be monitored for the e.Tects of this treatment on the growth of my tumor. 
By using techniques in the laboratory, it is now possible to prepare large amounts of 
human DNA or genetic material in bacteria. This DNA will be mixed with fat bodies 
called lipids, and then o-ansport the mixture into my rumor by needle injection. Once 
introduced into the tumor, the DNA produces proteins which it is hoped, based on 
animal studies, will stimulate tumor tissue rejection. One protein - known as HLVB7 
- causes the ceils which w;H contain it to be recognized as “foreign enemy” by the 
immune system. Toe purpose of the study is tc determine whether this treatment will 
induce the cells of my immune system, known as lymphocytes, to attack and kill the 
tumor. Tnis type of uhempy which stimulates lymphocytes is called immunctherapy. 
If I qualify' for this study, I will have a solution containing the DNA/lipid complex 
injected directly into a tumor nodule. The injections will be made under sterile 
conditions after providing a local anesthetic (.xylocame), and areas within a single 
nodule will be injected. The time of treatment is appro.ximacely 30 minutes. The 
treatment will be given once or repeated every 2 weeks for a total of three treatments 
depending on which group of the protocol I am placed. Blood samples (benveen 1-2 
ounces) will be obtained weekly or biweekly. A CT scan will be performed before 
initiation of treatment and once or nvice in the 2*month study period. My blood 
lymphocytes will be tested for their ability to respond to the HLA-B7 antigen. My 
blood N'-ili also be tested for evidence of tCMCtity (side effects) from this treaonenL 
At different times in the protocol, tumor biopsies will be performed. This procedure 
involves the injection of a local anesthetic (xylocaine) under sterile conditions, 
followed by insertion of a needle into the rumor nodule and withdrawal of a sample of 
the rumor. This procedure will be performed prior to treatment and at intervals of 2 
weeks up to 3 times. These tests will be in conjunction with the treatments. 
I will be checked regularly for any toxicity (side effect of the drug). Clinic visits 
will be required appro.ximately every week. In addition, a collection of small 
quantities of blood (2-6 teaspoons) for laboratory tests will be taken wee.kly and X- 
rays everv- 2 months and at the end of the study. The study may be terminated 
before that time by patient decision, side effects or if medically indicated. Patient 
foUow-up after study completion will be life-long. 
Recombinant DNA Research, Volume 19 
[255] 
