Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma (NCT04477200) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
United States68 participantsStarted 2020-08-05
Plain-language 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 glioblastoma or gliosarcoma.
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:
* 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 lymphop…
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
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
Timeframe: At 1 week
2
Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level
Timeframe: Up to 28 days following completion of MMF + RT (up to ~9 weeks)
3
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period
Timeframe: Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks)
4
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT2 Period
Timeframe: During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)