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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.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until study stops or death; up to approximately 3 years.
Awards & highlights

Study 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 am eligible for another round of radiation for my brain tumor as per my doctor's advice.
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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.
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My doctor recommends further surgery or biopsy for my brain tumor.

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

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

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,029 Total Patients Enrolled
4 Trials studying Glioblastoma
95 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,085 Total Patients Enrolled
322 Trials studying Glioblastoma
23,047 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have transpired regarding Radiation Therapy?

"At present, 129 separate studies are being conducted to research Radiation Therapy. Of those trials, 15 have progressed to Phase 3 and can be found in 841 locations worldwide; the majority of these clinical sites are situated in Philadelphia, Pennsylvania."

Answered by AI

What medical maladies has Radiation Therapy been found to effectively treat?

"Radiation Therapy is an effective method of treating the rejection reaction after organ transplants, such as liver and heart transplantations, or renal grafts."

Answered by AI

Is this experiment currently enrolling participants?

"Affirmative. Data from clinicaltrials.gov shows that this research endeavour, first posted on August 5th 2020, is actively recruiting participants. Sixty-eight individuals need to be enlisted across a single medical centre."

Answered by AI

What risks should individuals be aware of when undergoing Radiation Therapy?

"There is limited clinical evidence supporting the safety of Radiation Therapy, thus it scored a 1 on our scale."

Answered by AI

Can you explain the primary goals of this medical experiment?

"This clinical trial, lasting up to eleven weeks from the conclusion of MMF + RT + TMZ, intends to measure the number dose-limiting toxicities experienced by newly diagnosed phase 1 participants. Secondary objectives are determining median progression free survival in recurrent GBM/GS patients according to mRANO criteria, tabulating and categorizing any adverse events associated with treatment for new diagnosis phase 1 particpants, and measuring guanosine triphosphate (GTP) concentrations in plasma using mass spectrometry."

Answered by AI

How many participants have taken part in this research?

"Affirmative. Evidence on clinicaltrials.gov indicates that this research endeavour, which was originally advertised on August 5th 2020, is accepting applications. Approximately 68 trialists are required to be recruited from a single facility."

Answered by AI
~7 spots leftby Oct 2024