Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Фаза 1 Идёт, набор закрыт NCT04477200

Заболевание	Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
Фаза	Фаза 1
Спонсор	University of Michigan Rogel Cancer Center
Статус	Идёт, набор закрыт
Участники	68 участн.
Вмешательство	Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil
Дата начала	5.08.2020
Дата завершения	6.01.2025
Публикация результатов	14.05.2026

Кратко

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

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Другие исследования по этому заболеванию

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

Все исследования

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