Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

August 5, 2020

Primary Completion Date

January 6, 2025

Study Completion Date

November 5, 2027

Conditions
Recurrent GlioblastomaRecurrent GliosarcomaRecurrent Astrocytoma, Grade IVNewly Diagnosed GlioblastomaNewly Diagnosed GliosarcomaNewly Diagnosed Astrocytoma, Grade IV
Interventions
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

Trial Locations (1)

48109

University of Michigan Rogel Cancer Center, Ann Arbor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Michigan Rogel Cancer Center

OTHER

NCT04477200 - Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma | Biotech Hunter | Biotech Hunter