Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radia… (NCT07605364) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer
422 participantsStarted 2026-06-10
Plain-language summary
This phase II/III trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mycophenolate mofetil blocks enzyme activity which can disrupt tumor activity and may make the tumor more sensitive to radiation and/or temozolomide. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Temozolomide is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Giving mycophenolate mofetil with intensity-modulated radiation therapy and temozolomide may be more effective than intensity-modulated radiation therapy and temozolomide alone for the treatment of advanced glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed primary glioblastoma by World Health Organization (WHO) 2021 criteria
* No spinal cord glioblastoma
* No leptomeningeal disease
* No extracranial metastatic disease
* Patient is a candidate for first-line standard of care chemoradiation per treating physician(s)
* No prior treatment for glioblastoma other than resection (i.e. prior chemotherapy, radiation therapy, or other therapies such as laser ablation are not allowed)
* Prior biopsy and/or resection of glioblastoma must be completed at least 14 days prior to registration with adequate wound healing
* Age ≥ 18 years
* Karnofsky performance status (KPS) ≥ 60
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Platelet count ≥ 100,000 cells/mm\^3
* Hemoglobin (Hg) ≥ 9.0 g/dL
* Calculated (Calc.) creatinine clearance (CrCl) ≥ 25 mL/min
\* Calculated using the Cockcroft-Gault equation
* Bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0 x ULN
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
Women and men of reproductive potential must agree to use a highly effective method of birth control throughout their participation in this study and for at least 6 weeks (women) or 90 days (men) after last dose of treatment. R…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression free survival (PFS) (phase II)
Timeframe: From randomization to the disease progression according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause, up to 5 years
2
Overall survival (OS) (phase III)
Timeframe: From randomization until death due to any cause, up to 5 years