Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

1상 진행 중(모집 완료) NCT04477200

대상 질환	Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
임상 단계	1상
스폰서	University of Michigan Rogel Cancer Center
상태	진행 중(모집 완료)
참여자 수	68 명
중재(약물)	Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil
시작일	2020년 8월 5일
완료일	2025년 1월 6일
결과 공개일	2026년 5월 14일

요약

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
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3	2.65 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4	2.65 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5	1.8 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2	1.11 nmol/g
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3	0.81 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 3	0 number of patients reporting a DLT
Phase 1 - Recurrent GBM / GS - Level 4	0 number of patients reporting a DLT
Phase 1 - Recurrent GBM / GS - Level 5	0 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 3	0 number of patients reporting a DLT
Phase 1 - Newly Diagnosed GBM / GS- Level 4	0 number of patients reporting a DLT
Phase 1 - Newly Diagnosed GBM / GS- Level 5	5 number of patients reporting a DLT

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma — Wake Forest University Health Sciences
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblast — National Cancer Institute (NCI)
TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma — National Cancer Institute (NCI)
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant G — City of Hope Medical Center
Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma — L. Nicolas Gonzalez Castro, MD, PhD
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care — Bryan Allen

전체 임상

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