4.3 
Concomitant Medication and Treatment 
All allowed medications or treatments should be kept to a minimum and recorded. 
All questions regarding concomitant medications should be referred to the study 
chair or investigator. 
4.4 Medications and Treatments Not Allowed 
Corticosteroids 
5.0 CLINICAL AND LABORATORY EVALUATIONS 
5.1 Screening and Baseline Evaluations 
The following clinical and laboratory evaluations will occur within Study Days - 
30 to 0 unless otherwise noted. Screening evaluations, or evaluations that 
determine patient eligibility, are noted. These screening evaluations must be 
reviewed prior to study treatment. 
5.1.1 Objective Signs and Symptoms : include vital signs (blood pressure, pulse, 
temperature and respirations) weight and height. (Screening and repeat 
Day 0) 
5.1.2 History and Physical Examination : Screening, repeat targeted physical 
exam on Day 0 
5.1.3 Kamofskv Performance Status (see Appendix IV) (Screening) 
5.1.4 Chest X-Ray : Normal CXR within the last 30 days unless new symptoms 
suggest that this be repeated prior to dosing (Screening) 
5.1.5 Electrocardiogram (ECG): ECG must be normal within 30 days unless 
new symptoms suggest this be repeated prior to dosing (Screening) 
5.1.6 Urinalysis : Routine urinalysis including a 24-hour creatinine clearance 
(Screening and repeat Day 0) 
5.1.7 Serum Chemistries : include uric acid, calcium, phosphorus, magnesium, 
amylase, triglycerides, transaminases (SGOT, SGPT), alkaline 
phosphatase, LDH, total bilirubin, BUN, creatinine, albumin, total 
protein, electrolytes, and glucose (Screening) 
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