UAB 9405 
March 16, 1994 
PAGE - 14 
7.0 THERAPY MODIFICATION 
7.1 Polynucleotide Vaccine 
Local mild discomfort or aching at the site of injection will not alter dose or 
schedule decisions (Grade I) since this may simply reflect mild hematoma 
secondary to an intramuscular injection. 
If any patient develops grade 2 toxicity of any kind thought to be related to the 
vaccine, the study will be interrupted, clinical course evaluated further and further 
patient accrual dependent on review and approval by the FDA. It should be noted 
that the patient population will have metastatic colorectal cancer with associated 
symptoms (pain, nausea, emesis, fever) and that disease progression can occur 
over a six to eight week period of follow-up. 
If patients develop neutropenia, colitis or hepatitis, judged to be due to the vaccine 
and not to metastatic cancer, the study will be closed. 
Groups I to III represent single vaccination schedules of increasing doses. 
Progression to the next dose level will require that no patient in the current dose 
level has a Grade II or greater toxicity over two weeks of follow-up. 
Groups IV and V have repeat vaccine administrations and progression from 
Group IV to Group V will require that no patient in Group IV has a grade 2 
toxicity secondary to the vaccine over eight weeks of follow-up. 
7.2 Criteria for Removal from Study 
7.2.1 Intercurrent illness which prevents further doses of the vaccine. 
7.2.2 Development of clinically evident progression of disease. 
7.2.3 Unacceptable toxicity. 
7.2.4 Decision of the patient to withdraw from the study. 
Recombinant DNA Research, Volume 19 
[411] 
