BENITIONSClinical Trial Intelligence

Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

1期 进行中(已停止招募) NCT04477200

适应症Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
分期1期
申办方University of Michigan Rogel Cancer Center
状态进行中(已停止招募)
受试者人数68 人
干预(药物)Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil
开始日期2020年8月5日
完成日期2025年1月6日
结果公布日2026年5月14日

摘要

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 21.87 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 32.65 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 42.65 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 51.8 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 21.11 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 30.81 nmol/g

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 30 number of patients reporting a DLT
Phase 1 - Recurrent GBM / GS - Level 40 number of patients reporting a DLT
Phase 1 - Recurrent GBM / GS - Level 50 number of patients reporting a DLT

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 30 number of patients reporting a DLT
Phase 1 - Newly Diagnosed GBM / GS- Level 40 number of patients reporting a DLT
Phase 1 - Newly Diagnosed GBM / GS- Level 55 number of patients reporting a DLT

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。