2. Complete physical examination including, but not limited to vital signs , weight and oxygen saturation. 3. ECOG Performance Status. 4. Review of adverse events. 5. Injection site reaction assessment. 6. Clinical laboratory testing including but not limited to: CBC with differential and platelet count, total serum bilirubin, alkaline phosphatase, AST (SGOT), ALT (SGPT), serum creatinine, serum electrolytes, serum calcium , serum albumin and CPK. 7.