At a glance
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Phase 0/I Dose Escalation Study of Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
In Brief
A Phase 1 clinical trial evaluating Mycophenolate Mofetil, Radiation Therapy, and 2 other interventions for Recurrent Glioblastoma and 5 related conditions. Active but no longer recruiting, targeting 68 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)
40.5 Gy in 15 fractions
Re-resection or biopsy of tumor as part of standard of care
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.
250-2000mg orally twice daily, one week prior to and concurrent with RT.
250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
60 Gy in 30 fractions