Mycophenolate Mofetil Combined With Radiation Therapy in Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Oct 26, 2027
  • participants needed
    38
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 26 January 2021
mycophenolate mofetil
karnofsky performance status
glioblastoma multiforme
gliosarcoma

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 IdentifierNCT04477200
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Recurrent GBM or recurrent gliosarcoma
Karnofsky Performance Status 60 or greater
Candidate for clinically indicated re-resection or biopsy of glioblastoma or gliosarcoma per treating physician(s) (Phase 0)
Candidate for clinically indicated re-irradiation of glioblastoma or gliosarcoma per treating physician(s) (Phase 1)

Exclusion Criteria

Gliomatosis cerebri pattern (involving 3 or more different lobes) of disease
Leptomeningeal disease
Not willing to adhere to contraception (men and childbearing age women)
Known history of HIV
Active hepatitis B or C infection
Active systemic of central nervous system (CNS) infection
Serious intercurrent disease
Increase in steroid requirement within 7 days of study enrollment (stable or decreasing dose allowed)
Use of bevacizumab within 8 weeks of study enrollment
Radiation within 6 months prior to study enrollment (phase I)
Surgery within 4 weeks of re-irradiation (phase I)
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