SU101 administered on this schedule was generally well tolerated. The maximum tolerated dose of SU101 is 390 mg/m(2) per day for 4 days repeated every 3 weeks. The neurotoxicity observed at the 440 mg/m(2) per day dose level suggests that patients receiving repetitive cycles must be monitored closely, as SU0020 may accumulate over time.

9020 Background: Daily subcutaneous (SC) filgrastim reduces the duration of severe neutropenia in children receiving dose intensive chemotherapy. A single SC dose of pegfilgrastim may be as efficacious. Methods: We conducted a randomized, non-inferiority trial comparing neutrophil recovery, tolerability, and pharmacokinetics of pegfilgrastim (100 mcg/kg SC once/cycle) to filgrastim (5 mcg/kg SC daily until post nadir ANC >10,000) in children and young adults with newly diagnosed sarcoma treated with vincristine, doxorubicin, and cyclophosphamide (VDC) for cycles 1, 2, 5, 9, 11, 13 alternating with etoposide and ifosfamide (IE) for cycles 3, 4, 6–8, 10, 12, 14. Local control with radiation or surgery was initiated after cycle 5. Serum GCSF concentrations were monitored during cycle 1 and measured by ELISA. Complete blood counts were monitored thrice weekly during cycles 1–4. Cycle duration was collected for all cycles. Results: Accrual has been completed. 34 patients (median age 19 y, range 3–25 y) were enrolled, 28 have completed 4 cycles, and 26 have completed therapy. Growth factor associated toxicity included reversible transaminase elevation and arthralgias and was similar on the 2 treatment arms. For filgrastim (n=13) the median (range) GCSF Cmax was 12 ng/mL (4–16 ng/mL), Css was 7 ng/mL (2–9 ng/mL) and Tmax was 6 h (4–8 h). For pegfilgrastim (n=13), the median (range) GCSF Cmax was 69 ng/mL (11–235 ng/mL), Css was 43 ng/mL (7–151 ng/mL) and Tmax was 28 h (4–168 h). Median (range) neutrophil recovery and cycle duration are presented in the table. Conclusion: Pegfilgrastim was well tolerated. Peak and steady state serum GCSF concentrations were higher in patients receiving pegfilgrastim but more variable. The number of days of severe neutropenia and the cycle duration with single dose pegfilgrastim appear to be at least equivalent to daily filgrastim. [Table: see text] No significant financial relationships to disclose.

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