Could a transplant drug help fight glioblastoma?
NCT ID NCT04477200
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether adding the drug mycophenolate mofetil (MMF) to standard radiation therapy is safe for people with glioblastoma, an aggressive brain cancer. About 68 participants with newly diagnosed or recurrent glioblastoma will receive different doses of MMF along with radiation. The main goals are to find the highest safe dose and to measure how much drug reaches the tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mycophenolate mofetil (MMF), an immunosuppressant drug, combined with radiation therapy
- What this could lead to
- If successful, this could point toward a new way to treat glioblastoma by making radiation more effective.
- What could go wrong
- This is a very early (phase 0/1) trial with only 68 people, so it is mainly about safety and dosing. It may not lead to a proven treatment, and side effects from the drug or radiation could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
68 people
The number who actually took part.
- Started
-
Aug 2020
- Expected to finish
-
Nov 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * Lack of histopathological diagnosis of the tumor. * Gliomatosis cerebri pattern (tumor involving 3 or more lobes) of disease. * Leptomeningeal disease. * Use of bevacizumab within 8 weeks of study enrollment. * Known history of HIV. * Active hepatitis B or C infection. * 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. * Serious intercurrent disease. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Newly diagnosed astrocytoma, grade IV are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an immunotherapy drug outsmart a returning brain tumor?
- Can a RAGE inhibitor tame brain swelling after tumor surgery?
- Can a custom vaccine train the immune system to fight brain cancer?
- A simple lotion duo may shield skin from Tumor-Treating fields
- Can a modified herpes virus fight recurrent brain tumors?
- Can a new pill take on brain cancer?