Mycophenolate Mofetil Combined With Radiation Therapy in Recurrent Glioblastoma
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- STATUS
- Recruiting
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- End date
- Oct 26, 2027
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- participants needed
- 38
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- 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 recurrent glioblastoma or recurrent gliosarcoma.
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 (GBM). A small portion of the tumor, removed as part of clinical care, will be used for testing in this study. Thirty additional participants will be enrolled in the Phase 1 component of the trial. 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. Participants in Phase 0 who meet the eligibility criteria for the Phase 1 component may participate in both phases.
Details
| Condition | Recurrent Glioblastoma, Recurrent Gliosarcoma |
|---|---|
| Treatment | radiation therapy, mycophenolate mofetil, Re-resection (as part of standard of care) |
| Clinical Study Identifier | NCT04477200 |
| Sponsor | University of Michigan Rogel Cancer Center |
| Last Modified on | 26 January 2021 |
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