The main endpoint was progression zero cost survival at 6 months, secondary endpoints included response rate, all round survival, and toxicity. The examine was powered to detect an improvement in PFS six from 0. 15% to 0. 35% compared with historical controls. Patients had been treated in six week cycles with irinotecan at 125 mg/m2 weekly times four followed by two weeks off therapy and thalidomide beginning at 100 mg day by day and enhanced as tolerated to a greatest dose of 400 mg day by day. Sufferers had been evaluated with an MRI scan, which includes dynamic these details contrast enhanced photos, before and soon after every cycle of treatment. Thirty two evaluable sufferers have been enrolled while in the study. Eight individuals were alive and progression zero cost at six months. The PFS six was 25% and the median progres sion no cost survival was 13 weeks. The ideal responses have been CR in 1 patient, PR in one, and SD in 19. The general survival at six months was 62% and was 34% at 1 12 months.
The median general survival was 36 weeks. Adverse events incorporated diarrhea and abdominal cramps, lymphopenia, neutropenia, and fatigue. 4 individuals died even though on treatment, of those, two deaths had been considered quite possibly attributable to therapy linked toxicity. The combination of irinotecan and thalidomide selleck chemical Roscovitine exhibits promising activity in individuals with recurrent GBM not on EIAEDs. The outcomes of our review suggest that combining cytotoxic and antiangiogenic agents is an powerful tactic to the treatment of recurrent GBM, additionally they deliver a basis for exploring combination therapies much like the 1 in this review utilizing newer targeted antiangiogenic agents. TA 48. PHASE I TRIAL OF TEMODAR PLUS O6 BENZYLGUANINE 5 DAY Regimen FOR Patients WITH PROGRESSIVE GLIOBLASTOMA MULTIFORME J. A. Quinn, A. Desjardins, J. N. Wealthy, J. J. Vredenburgh, D. A. Reardon, S. Gururangan, S.
Sathornsumetee, A. Walker, K. N. Lavin, R. Birch, A. H. Friedman, H. S. Friedman, Duke University Health-related Center, Durham, NC, Keryx Biopharmaceuticals, Inc. Memphis, TN, USA We carried out a phase I clinical trial in individuals with progressive glioblas toma multiforme. This trial was intended to define the utmost tolerated dose of temozolomide administered for 5 con secutive days in combination with O6 benzylguanine. Two vary ent dosing regimens of temozolomide had been explored. On routine one, patients acquired 200 mg/m2/day on day one and 25 mg/m2/day on days 2 five. On routine 2, individuals acquired the same dose on all five days. The primary dose level for routine two was dependent on the MTD present in schedule one. O6 BG was administered the two as being a bolus infusion, in excess of 1 hour on day one and repeated each 48 hours on days three and 5, and like a steady infusion on days 1 five.