Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

  • End date
    Oct 23, 2027
  • participants needed
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 4 October 2022
mycophenolate mofetil
karnofsky performance status
glioblastoma multiforme


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.


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 or gliosarcoma (GBM/GS). A small portion of the tumor, removed as part of clinical care, will be used for testing in this study. Sixty additional participants will be enrolled in the Phase 1 component of the trial (30 with recurrent GBM/GS and 30 with newly diagnosed GBM/GS). 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 in recurrent GBM/GS and with radiation and chemotherapy in newly diagnosed GBM/GS. Participants in Phase 0 who meet the eligibility criteria for the Phase 1 component may participate in both phases.

Condition Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma, Newly Diagnosed Gliosarcoma, Newly Diagnosed Astrocytoma, Grade IV
Treatment radiation therapy, mycophenolate mofetil, Temozolomide, Re-resection (as part of standard of care)
Clinical Study IdentifierNCT04477200
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Glioblastoma or gliosarcoma (recurrent or newly diagnosed)
Karnofsky Performance Status 60 or greater
Phase 0: Candidate for clinically indicated re-resection or biopsy of glioblastoma or gliosarcoma per treating physician(s)
Phase 1, Recurrent: Candidate for clinically indicated re-irradiation of glioblastoma or gliosarcoma per treating physician(s) (No more than one prior course of radiation for GBM)
Phase 1, Newly Diagnosed: Candidate for upfront standard of care chemoradiation for glioblastoma or gliosarcoma per treating physician(s), to start no earlier than 14 days post- operatively from last definitive surgery for glioblastoma or gliosarcoma (if more than one surgery done. Ex. biopsy prior to resection)
ANC >=1,500 cells/mm^3 within 14 days prior to enrollment
Patient (men and childbearing age women) agrees to the use of highly effective contraception during study participation and for at least 6 weeks for female patients and 90 days for male patients after final MMF administration
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Leptomeningeal disease
Known history of HIV
Active hepatitis B or C infection
Lack of histopathological diagnosis of the tumor
Gliomatosis cerebri pattern (tumor involving 3 or more lobes) of disease
Serious intercurrent disease
Use of bevacizumab within 8 weeks of study enrollment
Active systemic or central nervous system (CNS) infection
Grade 4 lymphopenia (if ALC <0.5, patient must be on Pneumocystis jirovecii prophylaxis)
Estimated CrCl < 25 ml/min
History of organ transplantation
Patients with known hypoxanthine-guanine phosphoribosyl-transferase deficiency
History of allergic reaction or hypersensitivity to mycophenolate mofetil or mycophenolic acid or any component of the drug product; or medical contraindication for MMF per treating physician(s)
Known immunosuppressive condition from autoimmune disease, immune deficiency syndrome, or chronic immunosuppressive therapy
Inability to undergo MRI brain with and without contrast
Pregnant or lactating women
Patients with known phenylketonuria
Phase 0: Patients undergoing biopsy who are deemed unlikely to have sufficient tissue to spare for research purposes (e.g., those whose tumors are in an eloquent brain location where all tissue taken must be used for diagnostic purposes)
Phase I: Increase in steroid requirement within 7 days of study enrollment (stable or decreasing dose allowed)
Phase I, Recurrent: Radiation within 6 months prior to study enrollment
Phase I, Recurrent: Surgery within 4 weeks of re-irradiation
Phase I, Newly Diagnosed: History of hypersensitivity reactions to temozolomide or any other ingredients in temozolomide and dacarbazine
Phase I, Newly Diagnosed: Prior chemotherapy or radiation therapy for glioblastoma or gliosarcoma
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note