5. General or specific changes in the patient's condition which 
render the patient unacceptable for further treatment in the 
judgement of the investigator. 
IX. Reporting of Adverse Drug Reactions 
Adverse drug reactions will be reported to the DCT/NCI using the DCT/NCI 
Adverse Reaction Form for Investigational Agents. Toxicity will be graded 
according to the NCI Common Toxicity Criteria (Appendix 4). The telephone 
number and FAX for reporting ADR's is available 24 hours per day (recorder 
after working hours) as follows: 301-230-2330 and fax 301-230-0159. All 
written reports should be mailed to: 
Investigational Drug Branch 
P.O. Box 30012 
Bethesda, Maryland 20824 
Adverse drug reactions will be reported as follows. Report by telephone to IDB 
within 24 hours (301-230-2330, fax 230-0159): 
a. All life-threatening events (grade 4) which may be due to 
drug administration. 
b. All fatal events. 
c. The first occurrence of any previously unknown clinical 
event (regardless of grade). 
Written report to follow within 10 working days. 
X. Statistical Section 
This is a feasibility study. The major clinical endpoint is establishment of a 
safe dose of B7 transfected melanoma cell lines that can be administered 
repeatedly. 
The major laboratory endpoint is to determine whether the transfected and non- 
transfected cell line induces a specific T cell response to the melanoma 
antigen (s) presented by HLA-A1 and HLA-A2 . Comparisons will be made within 
patients to their baseline response, and between groups receiving transfected 
versus non-trans f ected cells. A 1-log increase in any measured parameter is 
considered biologically meaningful. 
XI. Collection of Data and Data Submission 
1. Data will be submitted to CTMS at least once every two weeks from each 
participating institution. 
2. The NCI/DCT case report form or ACES will be used to report to CTMS. 
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