Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma (NCT05236036) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
United States60 participantsStarted 2022-08-08
Plain-language summary
This phase I/Ib trial tests the safety, side effects, and best dose of mycophenolate mofetil in combination with temozolomide and/or radiation therapy (standard of care) in treating patients with glioblastoma. Mycophenolate mofetil is an immunosuppressant drug that is typically used to prevent organ rejection in transplant recipients. However, mycophenolate mofetil may also help chemotherapy with temozolomide work better by making tumor cells more sensitive to the drug. The purpose of this trial is to determine if mycophenolate mofetil combined with temozolomide can stop 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:
* GROUPS 1-3: Histologically confirmed glioblastoma (GBM), IDH wild-type (by immunohistochemistry \[IHC\] R132H negative \[neg\] or sequencing). Astrocytoma with molecular features of GBM are eligible.
* GROUPS 1-3: Newly diagnosed glioblastoma and:
* Group 1: Received surgical resection or biopsy followed by chemoradiation;
* Group 2: Received surgical resection or biopsy only and have documented unmethylated glioblastoma (may have been done at an outside facility);
* Group 3: Received surgical resection or biopsy only
* GROUP S: Newly suspected glioblastoma or recurrent glioblastoma, and scheduled to undergo a standard of care surgical resection or biopsy.
* Stable or decreasing dose of corticosteroids equivalent to =\< 8 mg dexamethasone daily, for \>= 7 days prior to registration.
* Note: There are no restrictions on steroid use on study
* Patients must be age \>= 18 years.
* Patients must exhibit a Karnofsky performance status \>= 70.
* Leukocytes (white blood cells \[WBC\]) \>= 3,000/mcL (within 14 days prior to study registration)
* Absolute neutrophil count (ANC) \>= 1,500/mcL (within 14 days prior to study registration)
* Hemoglobin (Hgb) \>= 8 g/dL (within 14 days prior to study registration) (transfusion may be used for eligibility if \>= 7 days)
* Platelets (PLT) \>= 100,000/mcL (within 14 days prior to study registration) (transfusion or growth factor may be used for eligibility if \>= 7 days).
* Total bilirubin =\< 2x institutional…
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
Maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) for mycophenolate mofetil (MMF) (Group 1)
Timeframe: Up to completion of first cycle of treatment + 7 days (1 cycle = 28 days)