A Phase 1 interventional study of Mycophenolate Mofetil and Radiation Therapy in Recurrent Glioblastoma, Recurrent Gliosarcoma and Recurrent Astrocytoma, Grade IV, sponsored by University of Michigan Rogel Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Michigan Rogel Cancer Center · Phase 1, Interventional, and Treatment
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.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 68 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Michigan Rogel Cancer Center is the lead sponsor of 323 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mycophenolate mofetil
Drug: Mycophenolate Mofetil · Procedure: Re-resection (as part of standard of care)
Mycophenolate mofetil; radiation therapy
Radiation: Radiation Therapy · Drug: Mycophenolate Mofetil
Mycophenolate mofetil; radiation therapy; temozolomide
Drug: Temozolomide · Drug: Mycophenolate Mofetil · Radiation: Radiation Therapy
500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)
Also known as: MMF
40.5 Gy in 15 fractions
Also known as: RT
Re-resection or biopsy of tumor as part of standard of care
Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Also known as: TMZ
250-2000mg orally twice daily, one week prior to and concurrent with RT.
Also known as: MMF
250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Also known as: MMF
60 Gy in 30 fractions
Also known as: RT
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
The concentration of MPA (the active metabolite of mycophenolate mofetil \[MMF\]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration. This measure includes all phase 0 participants.
Time frame: At 1 week
Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only phase 1 participants with recurrent GBM/GS.
Time frame: Up to 28 days following completion of MMF + RT (up to ~9 weeks)
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
Time frame: Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks)
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT2 Period
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
Time frame: During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)
Concentrations of Guanosine Triphosphate (GTP) in Tumor Tissue in Phase 0 Participants
The concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale. This measure includes all phase 0 participants.
Time frame: After one week of MMF administration
Adverse Events Associated With Treatment in All Phase 1 Participants
Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes all phase 1 participants.
Time frame: Up to 28 days following completion of MMF + RT (up to ~9 weeks)
Adverse Events Associated With Treatment in Newly Diagnosed Phase 1 Participants
Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes only newly diagnosed phase 1 participants.
Time frame: Up to 28 days following completion of MMF with adjuvant temozolomide (up to ~15 months)
Overall Response Rate in Phase 1 Participants With Recurrent GBM/GS
Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall. This measure includes only phase 1 participants with recurrent GBM/GS.
Time frame: Until study stops or death; up to approximately 3 years.
Median Progression Free Survival (PFS) in Phase 1 Participants With Recurrent GBM/GS
PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Time frame: Until study stops or death; up to approximately 3 years.
Median Freedom From Local Progression (FFLP) in Phase 1 Participants With Recurrent GBM/GS
FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Time frame: Until study stops or death; up to approximately 3 years.
Median Overall Survival (OS) in Phase 1 Participants With Recurrent GBM/GS
OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method. This measure includes only phase 1 participants with recurrent GBM/GS.
Time frame: Until study stops or death; up to approximately 3 years.
| Milestone | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 2 | 3 | 4 | 19 | 4 | 11 | 16 |
| Completed | 2 | 2 | 2 | 2 | 3 | 4 | 17 | 3 | 6 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 5 | 5 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 4 |
| Withdrew: Noncompliance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
The concentration of MPA (the active metabolite of mycophenolate mofetil \[MMF\]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration. This measure includes all phase 0 participants.
| nmol/g | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| Enhancing Tumor | 1.87 (1.55 to 2.19) | 2.65 (2.15 to 3.15) | 2.65 (1.74 to 3.56) | 1.8 (1.5 to 2.11) | — | — | — | — | — | — |
| Non- Enhancing Tumor | 1.11 (0.76 to 1.45) | 0.81 (0.81 to 0.81) | 1.53 (1.01 to 2.05) | 1.25 (0.72 to 1.79) | — | — | — | — | — | — |
| Normal Brain | — | 2.55 (2.55 to 2.55) | 2.59 (1.66 to 3.51) | 0.64 (0.4 to 0.88) | — | — | — | — | — | — |
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only phase 1 participants with recurrent GBM/GS.
| number of patients reporting a DLT | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level | — | — | — | — | 0 | 0 | 0 | — | — | — |
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
| number of patients reporting a DLT | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period | — | — | — | — | — | — | — | 0 | 0 | 5 |
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
| number of patients reporting a DLT | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT2 Period | — | — | — | — | — | — | — | 0 | 1 | 0 |
The concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale. This measure includes all phase 0 participants.
Results for this outcome have not been posted.
Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes all phase 1 participants.
Results for this outcome have not been posted.
Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes only newly diagnosed phase 1 participants.
Results for this outcome have not been posted.
Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall. This measure includes only phase 1 participants with recurrent GBM/GS.
Results for this outcome have not been posted.
PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Results for this outcome have not been posted.
FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Results for this outcome have not been posted.
OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method. This measure includes only phase 1 participants with recurrent GBM/GS.
Results for this outcome have not been posted.
Collected over Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | 1/2 (50%) | 0/2 (0%) | 0/2 (0%) |
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | 1/2 (50%) | 0/2 (0%) | 2/2 (100%) |
| Phase 1 - Recurrent GBM / GS - Level 3 | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| Phase 1 - Recurrent GBM / GS - Level 4 | 4/4 (100%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1 - Recurrent GBM / GS - Level 5 | 12/19 (63.2%) | 2/19 (10.5%) | 16/19 (84.2%) |
| Phase 1 - Newly Diagnosed GBM / GS - Level 3 | 2/4 (50%) | 1/4 (25%) | 4/4 (100%) |
| Phase 1 - Newly Diagnosed GBM / GS- Level 4 | 8/11 (72.7%) | 4/11 (36.4%) | 10/11 (90.9%) |
| Phase 1 - Newly Diagnosed GBM / GS- Level 5 | 11/16 (68.8%) | 9/16 (56.3%) | 16/16 (100%) |
| Event | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| AspirationRespiratory, thoracic and mediastinal disorders | 1/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| SeizureGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 1/4 | 3/11 | 1/16 |
| DysphasiaGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 1/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| Muscle weakness right-sidedMusculoskeletal and connective tissue disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 1/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| Aortic injuryBlood and lymphatic system disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 1/4 | 0/11 | 0/16 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 1/11 | 0/16 |
| Cerebrospinal fluid leakageGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 1/16 |
| FallGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 1/16 |
| FatigueGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 1/16 |
| HypokalemiaGeneral disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 1/16 |
| Event | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 |
|---|---|---|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 2/2 | 0/2 | 1/2 | 1/2 | 3/3 | 3/4 | 7/19 | 4/4 | 8/11 | 13/16 |
| ConstipationGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 4/4 | 7/11 | 12/16 |
| Lymphocyte count decreasedInvestigations | 0/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 0/19 | 2/4 | 7/11 | 15/16 |
| NauseaGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 2/3 | 1/4 | 6/19 | 2/4 | 9/11 | 14/16 |
| CushingoidRespiratory, thoracic and mediastinal disorders | 1/2 | 0/2 | 0/2 | 0/2 | 1/3 | 0/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| DeliriumPsychiatric disorders | 0/2 | 0/2 | 0/2 | 1/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| DepressionPsychiatric disorders | 0/2 | 0/2 | 1/2 | 0/2 | 0/3 | 0/4 | 0/19 | 0/4 | 0/11 | 1/16 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 0/2 | 1/3 | 0/4 | 0/19 | 0/4 | 0/11 | 0/16 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 1/2 | 0/2 | 0/2 | 0/2 | 0/3 | 0/4 | 1/19 | 1/4 | 0/11 | 2/16 |
| HeadacheGeneral disorders | 0/2 | 0/2 | 1/2 | 0/2 | 1/3 | 1/4 | 7/19 | 2/4 | 3/11 | 6/16 |
| Age, Categorical(Participants) | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 1 | 1 | 2 | 1 | 13 | 2 | 9 | 10 | 42 |
| >=65 years | 0 | 1 | 1 | 1 | 1 | 3 | 6 | 2 | 2 | 6 | 23 |
| Sex: Female, Male(Participants) | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 1 | 1 | 2 | 2 | 5 | 0 | 2 | 6 | 21 |
| Male | 1 | 1 | 1 | 1 | 1 | 2 | 14 | 4 | 9 | 10 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 2 | 2 | 2 | 2 | 3 | 4 | 18 | 4 | 11 | 16 | 64 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 |
| White | 2 | 2 | 2 | 2 | 3 | 4 | 15 | 4 | 10 | 16 | 60 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4 | Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5 | Phase 1 - Recurrent GBM / GS - Level 3 | Phase 1 - Recurrent GBM / GS - Level 4 | Phase 1 - Recurrent GBM / GS - Level 5 | Phase 1 - Newly Diagnosed GBM / GS - Level 3 | Phase 1 - Newly Diagnosed GBM / GS- Level 4 | Phase 1 - Newly Diagnosed GBM / GS- Level 5 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| United States | 2 | 2 | 2 | 2 | 3 | 4 | 19 | 4 | 11 | 16 | 65 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in Jan 2025, 53 months.
Results were first posted in May 2026, 1 year 4 months after primary completion.
Of 240 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's 53 months is above that.
Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center →