NCT04477200

Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Phase 0/I Dose Escalation Study of Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of the Phase 0 component is to determine if MMF achieves active concentrations in brain tumors. Eight participants in Phase 0 will receive MMF for one week before undergoing an already planned biopsy or re-resection (surgical removal) of glioblastoma or gliosarcoma (GBM/GS). A small portion of the tumor, removed as part of clinical care, will be used for testing in this study. Sixty additional participants will be enrolled in the Phase 1 component of the trial (30 with recurrent GBM/GS and 30 with newly diagnosed GBM/GS). The goal of the Phase 1 component is to find the dose of MMF that works best without causing severe side effects (the maximum tolerated dose) when combined with radiation in recurrent GBM/GS and with radiation and chemotherapy in newly diagnosed GBM/GS. Participants in Phase 0 who meet the eligibility criteria for the Phase 1 component may participate in both phases.

Conditions

• Recurrent Glioblastoma
• Recurrent Gliosarcoma
• Recurrent Astrocytoma, Grade IV
• Newly Diagnosed Glioblastoma
• Newly Diagnosed Gliosarcoma
• Newly Diagnosed Astrocytoma, Grade IV

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)
RADIATION	Radiation Therapy	40.5 Gy in 15 fractions
PROCEDURE	Re-resection (as part of standard of care)	Re-resection or biopsy of tumor as part of standard of care
DRUG	Temozolomide	Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
DRUG	Mycophenolate Mofetil	250-2000mg orally twice daily, one week prior to and concurrent with RT.
DRUG	Mycophenolate Mofetil	250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
RADIATION	Radiation Therapy	60 Gy in 30 fractions

Timeline

• Start date: 2020-08-05
• Primary completion: 2025-01-06
• Completion: 2027-11-05
• First posted: 2020-07-20
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study