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Title:
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Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma - IRB# 10-039A
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Treatments:
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Everolimus, Radiation Therapy, Temozolomide
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Disease Site:
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Brain
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Disease SubSite:
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Glioblastoma multiforme
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Drug Provided:
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Everolimus
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Comments:
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Eligibility:
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Histologically confirmed diagnosis of 1 of the following: Glioblastoma multiforme (grade 4 astrocytoma), Other grade 4 astrocytoma variants (e.g., giant cell), Gliosarcoma, Newly diagnosed disease, Some patients may be registered on protocol NCCTG-947252, No oligodendrogliomas or oligoastrocytomas. Prior/Concurrent Therapy: Inclusion criteria: At least 1 week, but no more than 6 weeks since prior surgical resection or biopsy, Must comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week), oral dapsone (daily) combined with daily levofloxacin, or monthly pentamidine (inhaled or IV) combined with daily levofloxacin. Exclusion criteria: Prior chemotherapy for any brain tumor. Prior temozolomide or mTOR inhibitor therapies. Any prior cranial radiotherapy, Planned immunization with attenuated live vaccines during study period, At least 21 days since prior major surgery (excluding neurosurgical biopsy, resection of brain tumor, or treatment of immediate post-neurosurgical complication [e.g., intracranial hematoma]), Concurrent or prior treatment for this cancer with any other investigational agents, Concurrent enzyme-inducing anticonvulsants (EIACs) or other strong inducers of CYP3A4 (i.e., carbamazepine, phenytoin, phenobarbital/primidone, rifabutin, rifampin, or St. John's wort), Concurrent therapeutic doses of warfarin, Low molecular weight heparin is allowed, Concurrent systematic leukocyte growth factors (e.g., G-CSF or GM-CSF), except for the treatment of severe neutropenia, Concurrent drugs or substances known to inhibit or induce CYP3A, Other concurrent chronic treatment with immunosuppressive agents except Dexamethasone, Other concurrent anticancer agents.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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