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Immunosuppressant

Mycophenolate Mofetil + Radiation for Glioblastoma

Phase 1

Recruiting

Led By Nathan Clarke, 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

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ until study stops or death; up to approximately 3 years.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

~1930

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

295 Previous Clinical Trials

24,222 Total Patients Enrolled

4 Trials studying Glioblastoma

95 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,333 Total Patients Enrolled

324 Trials studying Glioblastoma

23,120 Patients Enrolled for Glioblastoma

Nathan Clarke, 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 Oct 2024

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