Should toxicity occur, appropriate therapeutic intervention will be instituted. Patients will be followed 
until toxicity resolves. 
A summary of the treatment plan including the schedule for drug administration and required monitoring 
evaluations in 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 ftirther 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 
diseaseprogression/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. 
9.1.2 All life-threatening and lethal (grade 4 and 5) toxicity. 
9.1.3 Grade 2 and grade 3 toxicity. 
9.2 Types of Reports 
9.2.1 Telephone Report. All life-threatening and lethal (grade 4 and 5) toxicity must be reported 
to IDB (301-230-2330) and the study chair by telephone within 24 hours. 
9.2.2 Written Report. An original NCI Adverse Drug Reaction form and 2 copies must be 
submitted to the study chair within 5 days. Immediately upon receipt the chair will forward the original 
report to NCI. 
9.3 Response Criteria 
9.3.1 Following the first three cycles of treatment, an evaluation of response will be performed. 
Tumor size will be calculated by measuring the tumor's largest cross sectional area as measured by the 
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