Before acceptance of patients for this protocol, the investigator(s) will explain 
specifically the following to the patient and/or parents: 
1. The nature of a Phase I study. 
2. That the patient’s tumor is resistant to conventional therapeutic agents, but there 
exists a chance that therapeutic benefits may be detected following treatment 
with IL-2 gene modified autologous tumor cells, but that no benefit may be seen. 
3. That antitumor activity has been demonstrated in animals and that a similar 
approach is being investigated at NIH for activity in adults with cancer. 
4. That certain toxic side effects have been encountered in human subjects. 
5. That these side effects have included local reactions. 
6. That blood samples will be obtained over a period of time during and after the 
injection of modified tumor cells. 
7. That this therapy precedes rather than replaces standard chemo/radiotherapy. 
8. That the patient and/or parents are asked to sign a statement signifying that they 
have read and do understand an account of the possible side effects of the agent 
and that the patient or parents have the right to withdraw the subject from 
participation in the study at any time. 
9. That the patient’s participation in these studies is voluntary and that no financial 
remuneration is available for participating in this study, but that all necessary 
therapeutic measures will be provided should toxicity ensue, and that the records 
of the treatment of the subjects will be kept confidential but may be reviewed 
by representatives of the National Cancer Institute, Food and Drug 
Administration, or pharmaceutical manufacturers, and that a copy of the signed 
consent form will be furnished to the patient and/or parents. 
10. That a copy of the signed consent form will be furnished to the patient and/or 
parents. 
If there is conflict between the parent’s and child’s wishes patients will have an 
opportunity to discuss the proposal with a representative from the social services or 
psychology departments, who will serve as a patient advocate and who should also 
witness the consent. 
Recombinant DNA Research, Volume 15 
[761] 
