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ACTIVE NOT RECRUITING
NCT04477200
PHASE1

Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2020-08-05

Completion Date

2027-11-05

Last Updated

2025-06-29

Healthy Volunteers

No

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

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States