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Immunosuppressant

Mycophenolate Mofetil + Radiation for Glioblastoma

Phase 1
Recruiting
Led By Yoshie Umemura, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status 60 or greater.
Glioblastoma or gliosarcoma (recurrent or newly diagnosed).
Must not have
Leptomeningeal disease.
Phase I, Newly Diagnosed: Prior chemotherapy or radiation therapy for glioblastoma or gliosarcoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until study stops or death; up to approximately 3 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that combines a drug called Mycophenolate Mofetil with radiation. The goal is to find the highest dose of the drug that can be given without causing serious side effects.

Who is the study for?
This trial is for adults with glioblastoma or gliosarcoma, either newly diagnosed or recurrent. They must be candidates for surgery, radiation therapy, and agree to use effective contraception. Excluded are those with serious infections, organ transplants, certain medical conditions like phenylketonuria or hypoxanthine-guanine phosphoribosyl-transferase deficiency, pregnant women, and anyone who can't undergo MRI scans.
What is being tested?
The study tests the highest dose of Mycophenolate Mofetil (MMF) that patients can tolerate alongside radiation therapy for brain cancer treatment. It's a phase 0/1 trial where doses increase gradually to find the safe limit. Standard treatments like surgery and Temozolomide may also be used.
What are the potential side effects?
Possible side effects of MMF include digestive problems such as diarrhea and vomiting; blood issues like anemia; increased risk of infection due to immune system suppression; liver function changes; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I have been diagnosed with glioblastoma or gliosarcoma.
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I am newly diagnosed with glioblastoma or gliosarcoma and can start treatment at least 14 days after my last surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the lining of my brain and spinal cord.
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I have not had chemotherapy or radiation for my newly diagnosed glioblastoma or gliosarcoma.
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I have been diagnosed with HIV.
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I received radiation for a recurring condition within the last 6 months.
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My brain tumor affects three or more lobes.
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I have had an organ transplant.
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I have a deficiency in an enzyme called hypoxanthine-guanine phosphoribosyl-transferase.
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I have a condition that weakens my immune system.
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I am allergic to temozolomide or dacarbazine.
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I do not have an active infection in my body or brain.
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I am allergic to or cannot take mycophenolate mofetil or mycophenolic acid due to a doctor's advice.
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I have phenylketonuria.
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I have not increased my steroid dose in the last 7 days.
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My tumor has not been diagnosed through tissue examination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until study stops or death; up to approximately 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and until study stops or death; up to approximately 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of mycophenolic acid (MPA) in tumor tissue in Phase 0 participants
Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT1 period
Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT2 period
+1 more
Secondary study objectives
Adverse events associated with treatment in all Phase 1 Participants
Therapeutic procedure
Concentrations of guanosine triphosphate (GTP) in tumor tissue in Phase 0 participants
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 1 - Recurrent GBM / GSExperimental Treatment2 Interventions
Mycophenolate mofetil; radiation therapy
Group II: Phase 1 - Newly Diagnosed GBM / GSExperimental Treatment3 Interventions
Mycophenolate mofetil; radiation therapy; temozolomide
Group III: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)Experimental Treatment2 Interventions
Mycophenolate mofetil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,297 Total Patients Enrolled
4 Trials studying Glioblastoma
81 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,068 Total Patients Enrolled
330 Trials studying Glioblastoma
23,308 Patients Enrolled for Glioblastoma
Yoshie Umemura, MDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Media Library

Mycophenolate Mofetil (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04477200 — Phase 1
Glioblastoma Research Study Groups: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS), Phase 1 - Recurrent GBM / GS, Phase 1 - Newly Diagnosed GBM / GS
Glioblastoma Clinical Trial 2023: Mycophenolate Mofetil Highlights & Side Effects. Trial Name: NCT04477200 — Phase 1
Mycophenolate Mofetil (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477200 — Phase 1
~3 spots leftby Feb 2025
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