abnormalities of kidney, liver, and central nervous system function. These will 
be graded by the criteria listed under Section 9.3 below. 
9.3 The maximum tolerated dosage will be defined as the highest dosage which does 
not cause Grade 3 or 4 toxicity described below. 
9.3.1 Skin Toxicitv : Any local skin reaction (exfoliative or ulcerating) 
requiring medication, or reaction which progresses to ulceration. 
Any evidence of growth of injected tumor cells confirmed on biopsy. 
9.3.2 Hematologic Toxicitv : Neutrophils <500/mm 3 , platelets <25000/mm 3 , 
hemoglobin <6.5 gm/dl for greater than 5 days. 
9.3.3 Renal Toxicitv : Serum creatinine >6 mg/dl which is reversible, or any 
irreversible increase of serum creatinine >2 mg/dl. 
9.3.4 Hepatic Toxicitv : Serum bilirubin >1.5 mg/dl, SGOT >20 x normal, or 
any evidence of irreversible deterioration in liver function (hepatic 
coma). 
9.3.5 Cardiac Toxicitv : Any evidence of congestive heart failure or serious 
arrhythmias, tachycardia or fibrillation, transient or persistent requiring 
monitoring, or hypotension requiring therapy and hospitalization for 
more than 48 hours or hypertension requiring therapy. 
9.3.6 Gastrointestinal Toxicitv : Serous mucositis which prevents oral intake 
for more than 3 days after treatment of drug administration, or diarrhea 
requiring hospitalization for fluid replacement. 
9.3.7 Central Nervous System Toxicitv : Any grade 3 or 4 neurotoxicity as 
defined for mental status, motor system, cranial nerves, cerebellar 
function or seizures. 
9.3.8 Pulmonary Toxicitv : Irreversible decrease of pulmonary function of 
>10% as evidenced by arterial blood gases or interstitial pulmonary 
fibrosis by chest radiographs, with associated dyspnea at rest. 
9.4 Stopping Rule 
Three or more patients will be entered at each dosage level described in 6.1.6. 
If 1 patient develops any of the above Grade 4 hematologic/non-hematologic 
toxicities, an additional 3 patients will be evaluated at that dosage level. If none 
of these latter 3 patients experience dose limiting toxicity, then the dosage is 
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