Mycophenolate Mofetil Combined With Radiation Therapy in Recurrent Glioblastoma

• Status: Recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Rogel Cancer Center
• Treatments: Mycophenolic Acid

Criteria

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)