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Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
Sponsor: University of Michigan Rogel Cancer Center
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
Conditions
Interventions
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 Therapy
40.5 Gy in 15 fractions
Re-resection (as part of standard of care)
Re-resection or biopsy of tumor as part of standard of care
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.
Mycophenolate Mofetil
250-2000mg orally twice daily, one week prior to and concurrent with RT.
Mycophenolate Mofetil
250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy
60 Gy in 30 fractions
Locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States