3.3 Patient’s Financial Responsibilities During the Study 
A grossly exaggerated upper limit is outlined in the Informed Consent Form at 
the request of the UCLA IRB. 
14.0 CRITERIA AND PROCEDURES FOR PROTOCOL MODIFICATION AND 
STUDY TERMINATION 
Modifications which may effect the safety of the study patient, or which may alter the 
scope of the investigation, the scientific quality of the study, the study design, dosages, 
duration of therapy, patient assessments (added evaluation that poses potential risk or 
inconvenience to the patient), number of patients, and patient eligibility criteria, may be 
made only after appropriate consultation between the sponsor and the investigator. 
If the consensus is to revise the current protocol, a formal List of Changes will 
accompany the amended protocol and these will be submitted to the FDA, the site’s IRB, 
and other committees as required. 
Both the sponsor and the investigator reserve the right to terminate the study at any time. 
If this becomes necessary, appropriate procedures for continuing the long-term follow-up 
requested by the regulatory agencies will be arranged after review and approval by both 
parties. 
15.0 REFERENCES 
1. Musiani, P., De Campora, E., Valitutti, S., Castellino, F., Calearo, C., 
Cortesina, G., Giovarelli, M., Jemma, C., De Stefani, A. & Fomi, Guido. 
Effect of Low Doses of Interleukin-2 Injected Perilymphatically and Peritumorally 
in Patients with Advanced Primary Head and Neck Squamous Cell Carcinoma. 
J Biol Response Modifiers 8:571-578, 1989. 
2. Russell, S.J., Flemming, C., Eccles, S.A., Johnson, C. and Collins, M.K.L. 
Transfer and Expression of the Human IL-2 Gene in a Transplantable Rat 
Sarcoma. Cell Immunity & the Immunother of Cancer 275-278, 1990, Wiley- 
Liss Inc. 
3. Kim, TS, Russell, SJ, Collins, M.K.L., and Cohen, E.P. Immunity to B16 
Melanoma in Mice immunized with IL-2-Secreting Allogeneic Mouse Fibroblasts 
Expressing Melanoma-Associated Antigens. Int. J. Cancer 51: 1-7, 1992. 
4. Russell, S .J., Eccles, S.A, Flemming, C.L., Johnson, C.A., and Collins, M.K.L. 
Decreased Tumorigenicity of Transplantable Rat Sarcoma Following Transfer and 
Expression of an IL-2 cDNA. Int. J. Cancer 47:244-251, 1991. 
5. Gansbacher, B., Zier, K., Daniels, B., Cronin, K., Banneiji, R., and Gilboa, G. 
Interleukin 2 Gene Transfer into Tumor Cells Abrogates Tumoricenicity and 
Induces Protective Immunity. J. Exp. Med. 172:1217-1224, 1990. 
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