H444 P04 
FEE-24- ’94 THU 14:37 ID: HEnHTOLOGY-ONCOLDGY FAX NO: 602-626-2225 
SUBJECTS' CONSENT FORM 
Appr. Date: 11/23/93 TITLE: Phase I Saidy of Immunotherapy 
Rev-. 1/13/94 of Malignant Melanoma by 
Direct Gene Transfer 
Page _l_of_5_ 
Number. 
SWOG: 
HSC; 93-175 
Revised Consent Form 
I am are BEI.VG asked to R£\D the following material to ensure that I AM 
INTORMED OF THE NATURE OF THIS RESEARCH STUDY AND OF HOW I WILL PARTICIPaTEI / 1 3/9. 
IN IT, IF 1 CONSENT TO DO SO. SIGNING THIS FORM WILL INDICATE THaT I HAVE BEEN SO 
INFORxMED ANT) THAT I GM MY CONSENT. FEDERAL REGULATIONS RBaUTRE WRITTEN 
INTORMED CONSENT PRIOR TO PARTICIPATION IN THIS RESEARCH STUDY SO THAT I 
KNOW THE NATURE AND THE RISKS OF MY PARTICIPATION AND CAN DECIDE TO 
P.ARTICIPATE OR NOT PARTICIPATE IN A FREE AND INTORMED MANNER. 
PUTIPOSE 
I am being invited to voluntarily participate in the above-titled research project. 
The purpose of this project is to evaluate the toxidty (side effects and safety of gene 
therapy of malignant melanoma by introducing a manufactured gene substance into 
a melanoma rumor nodule. It is hoped to induce immunity to the melanoma. 
However, this is a phase I study which means it is designed to test the safety of 3 
different doses of the gene given 1, 2 or 3 times and has no assurance that it will have 
any benefit, although any effect on rumor size will be observed. 
SP FCnON CRITERIA 
I am being invited to participate because I have metastatic malignant melanoma 
which means that the tumor (cancer) has spread to lymph nodes (glands) or internal 
organs such as liver or lung. Furthermore, my rumor is no longer or not amenable to 
conventional treacmen: with surgery, radiation or approved drags. 
If I am female I must not be pregnant or nursing. Men and women of chiild-bearing 
age and capacity must use effective birth control during study participation 
(condoms are highly encouraged). 
A total of up to 15 patients will be enrolled at the .Arizona Cancer Center. 
STANDARD TREAlMENTIS) 
The.'-e are no known cures for patients with my disease. Also, before being eligible 
for this protocol I will have failed on or been unable to tahe front line chemotherapy 
which has a 50% response rate. Alternative treatments available to me include the 
delivery of x-ray treatment to sites of local disease (50%) response rate), medication 
to control pain (close to 100% response rate) and certain established chemotherapy 
treatments or e.\perimentaJ drugs are being evaluated at other centers to which I can 
be referred. Tnese could have response rates In the range of 20% but this is not 
cenain as they are e.xperimeatai. Experimental treatments are under investigation 
which attempt to stimulate the immune system to reject the rumor, and I can be 
referred to physicians who are conducting such trials. In some cases, proteins are 
injected which can stimulate the immune system. I also have the option to receive no 
treatment at this time. 
PROCEDURE 
Within 14 days before I start the test injections, I will have a complete history and 
physical evaluation, electrocardiogram (ECG), urinalysis, blood work (complete blood 
count or CBC), differencial and platelets, blood chemistries, pregnancy test, hepadds 
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Recombinant DNA Research, Volume 19 
