9. 1.1.2 All life-threatening and lethal (grade 4 and 5) toxicity. 
9. 1.1. 3 Grade 2 and grade 3 toxicity. 
9.1.2 Types of Reports 
9. 1.2.1 Telephone Report. All life-threatening and lethal (grade 4 and 5) reactions must 
be reported to the study chair by telephone within 24 hours. 
9. 1.2.2 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. 
9.2 Response Criteria 
9.2.1 Following the first two 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 greatest cross sectional diameter times the greatest diameter perpendicular to it on 
enhanced CT or MRI. Technical parameters for the evaluation scan will be identical to those used for 
the baseline scan. 
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9.2.2 A physical examination will be performed and compared with the pretreatment 
examination. 
9.2.3 A Kamofsky performance will be recorded and compared with the pretreatment score. 
9.2.4 Medications and their dosages, including steroids, and laboratory data will be recorded 
in accordance with the study parameters above. 
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9.2.5 Response will be defined as summarized below. 
Complete Response (CR): Disappearance of all measurable or evaluable disease, signs, symptoms 
and biochemical changes related to the tumor, for > 4 weeks, during which time no new lesions may 
appear. At the time of suspected CR, re-evaluate completely, short of invasive procedures. If hepatic 
or BM involvement were documented histologically, rebiopsy is required. 
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Equivocal Complete Response (Equiv. CR): This rating will be assigned where there is a complete 
response, but examination remains abnormal in such a way as to preclude an unequivocal statement 
that the tumor has completely disappeared. 
Partial Response (PR): This rating will be assigned where there is a reduction by at least 50% of the 
product of the two longest perpendicular diameters of the lesion(s). A bone response consisting of 
recalcification of lytic bone metastasis will be included as partial response providing there has been no 
disease progression elsewhere. 
Minor Response (MR): This rating will be assigned where there is a reduction of less than 50% of 
the product of the two longest perpendicular diameters of the lesion(s), and either no change in or 
partial recalcification of all osteolytic lesions. 
Objectively Stable (S): This rating will be assigned where there is less than 25% increase in the 
product of the two longest perpendicular diameters of the lesion(s). 
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