Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Phase 1 Active, not recruiting NCT04477200

Condition	Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
Phase	Phase 1
Sponsor	University of Michigan Rogel Cancer Center
Status	Active, not recruiting
Enrollment	68 participants
Interventions	Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care), Temozolomide, Mycophenolate Mofetil
Start date	Aug 5, 2020
Completion date	Jan 6, 2025
Results posted	May 14, 2026

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

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

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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