8.2 Follow-up Procedures 
After each immunization, patients will be contacted daily for 3 days to determine if the injection site 
is swollen or red. If a history of any erythema or induration is elicited, then the patient will be 
examined within 24 hours. Otherwise, subjects will be examined one week after the first 
immunization, then at approximately 1 to 2 week intervals. At each visit, the patients will be advised 
to return to the hospital and to contact one of the study investigators should they develop inflammation 
at injection sites or experience fever, rash, arthralgias, edema or dyspnea. 
At each visit, the pertinent medical history will be obtained and a physical examination 
performed. Laboratory tests described in Section 8.1 will be performed at the weekly and 
visits. 
Diagnostic studies including X-rays, CT, MRI or radionuclide scans will be performed to 
responses to therapy. 
Should toxicity occur, appropriate therapeutic intervention will be instituted. Patients 
followed until toxicity resolves. 
A summary of the treatment plan including the schedule for drug administration and 
monitoring evaluations is provided in Section 3.0. 
8.3 Off-Study Criteria 
8.3.1 A patient will be considered off treatment once protocol therapy has been stopped. 
Reasons for discontinuation of treatment include: 
Development of grade _>3 toxicity 
Patient's tumor fails to respond to treatment (progressive disease) 
Patient has completed therapy 
Patient refuses further therapy 
Patient develops other medical problems unrelated to the study that preclude further therapy. 
8.3.2 A patient will be considered off study in the event of disease progression, death or 
initiation of non-protocol treatment. 
8.3.3 A patient who is off study will be off treatment; however, a patient who is off 
treatment is not necessarily off study. 
8.3.4 Patients who are off treatment but not off study will continue to be followed for disease 
progression/response, late reports of toxicity and survival. Once a patient is off study because of 
disease progression or initiation of non-protocol treatment, the patient will be followed for survival 
purposes. 
9.0 Evaluation Criteria 
9.1 Adverse Drug Reaction Reporting 
9.1.1 Reporting Requirements 
The following adverse reactions must be reported to the study chair and the NCI, in addition, the 
institutions' IRB (Investigational Review Board) must be notified. 
will be 
monthly 
evaluate 
will be 
required 
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