Abstract
1521 Background: TMZ, an oral alkylating agent is active in recurrent malignant glioma. CPT-11, a topoisomerase I inhibitor, has also been shown to have modest activity in recurrent malignant glioma. A phase I study by NABTC has demonstrated the safety of combining TMZ and CPT-11 in a q2-week schedule and established the MTD of CPT-11 at 500 mg for patients receiving p450 enzyme inducing anticonvulsant (Group B). This phase II study is to further establish the efficacy of this combination in pts with recurrent malignant glioma. Methods: This is a multicenter phase II trial. All pts had documented recurrent GBM or Anaplastic Gliomas (AA, AO, AOA). TMZ was given at 150 mg/m2/d x 5, q 28d. For pts not receiving p450 enzyme inducing anticonvulsant (Group A), CPT-11 was given at 200 mg/m2, q2-wk, while 500 mg/m2 q2-wk, was given to Group B pts. Results: 51 GBM and 17 AG pts were entered into the study (50 Group A, 18 Group B). Demographic and preliminary outcome data are listed in the table below. Response data (not yet centrally reviewed) was available in 57 pts (44 GBM, 13 AG). Follow-up data were available in 43 pts (32 GBM, 11 AG) to assess progression free survival at 6 months (PFS6). No unusual toxicities were encountered. Most common toxicities include Leukopenia, thrombocytopenia, diarrhea, nausea, and vomiting. Conclusions: The combination of TMZ and CPT-11 in this schedule is active and tolerable. The response rate and PFS6 for GBM pts were better than single agent TMZ or CPT-11 for recurrent GBM, while that for AG were the same as single agent. A phase II study with this combination for newly diagnosed GBM is ongoing by the Radiation Therapy Oncology Group. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis, Pfizer, Pharmacia, Schering-Plough EMD, Genentech, Novartis, Pfizer, Schering-Plough Genentech, Novartis, Pfizer, Schering Plough
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