Spots Global Cancer Trial Database for Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

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Trial Identification

Brief Title: Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

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

Study ID: NCT04477200

Conditions

Recurrent Glioblastoma

Recurrent Gliosarcoma

Recurrent Astrocytoma, Grade IV

Newly Diagnosed Glioblastoma

Newly Diagnosed Gliosarcoma

Newly Diagnosed Astrocytoma, Grade IV

Interventions

Mycophenolate Mofetil

Radiation Therapy

Re-resection (as part of standard of care)

Temozolomide

Mycophenolate Mofetil

Radiation Therapy

Study Description

Brief 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.