Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
第1相
実施中（募集終了）
NCT04477200
| 対象疾患 | Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma |
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| 相 | 第1相 |
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| スポンサー | University of Michigan Rogel Cancer Center |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 68 名 |
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| 介入（薬剤） | Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil |
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| 開始日 | 2020年8月5日 |
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| 完了日 | 2025年1月6日 |
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| 結果公開日 | 2026年5月14日 |
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概要
This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
At 1 week · nmol/g
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | 1.87 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | 2.65 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | 2.65 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | 1.8 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | 1.11 nmol/g |
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| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | 0.81 nmol/g |
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Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level
Up to 28 days following completion of MMF + RT (up to ~9 weeks) · number of patients reporting a DLT
| Phase 1 - Recurrent GBM / GS - Level 3 | 0 number of patients reporting a DLT |
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| Phase 1 - Recurrent GBM / GS - Level 4 | 0 number of patients reporting a DLT |
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| Phase 1 - Recurrent GBM / GS - Level 5 | 0 number of patients reporting a DLT |
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Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period
Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks) · number of patients reporting a DLT
| Phase 1 - Newly Diagnosed GBM / GS - Level 3 | 0 number of patients reporting a DLT |
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| Phase 1 - Newly Diagnosed GBM / GS- Level 4 | 0 number of patients reporting a DLT |
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| Phase 1 - Newly Diagnosed GBM / GS- Level 5 | 5 number of patients reporting a DLT |
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