← Back to Search

Immunosuppressant

Mycophenolate Mofetil + Standard Care for Glioblastoma

Phase 1

Recruiting

Led By Priya U Kumthekar, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically confirmed glioblastoma (GBM), IDH wild-type or astrocytoma with molecular features of GBM

Patients with Karnofsky performance status >= 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a drug called mycophenolate mofetil when given with the standard treatment for glioblastoma (a type of brain cancer). 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.

Who is the study for?

Adults diagnosed with glioblastoma, who've had surgery or biopsy and are stable on low-dose corticosteroids. They must be able to perform daily activities (Karnofsky score >=70), have adequate organ function, and agree to use contraception. Excluded are those with other cancers, certain infections, uncontrolled illnesses, pregnant/nursing women, inability to take oral meds, or known HIV/HBV/HCV.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dose of Mycophenolate Mofetil when combined with standard treatments for glioblastoma: Temozolomide and Radiation Therapy. The goal is to see if this drug makes cancer cells more sensitive to treatment.See study design

What are the potential side effects?

Mycophenolate Mofetil may cause immune system suppression leading to a higher risk of infections. Other side effects can include upset stomach, blood cell changes increasing infection risk or bleeding problems, liver issues, and potential interactions with live vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor is confirmed as glioblastoma or has similar features.

Select...

I am mostly able to care for myself.

Select...

I have a new glioblastoma diagnosis and have had surgery or biopsy, with or without chemoradiation.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

MTD/RP2D for MMF (Group 2)

Maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) for mycophenolate mofetil (MMF) (Group 1)

Secondary outcome measures

Frequency of adverse events

Overall response rate (ORR)

Overall survival (OS)

+2 more

Other outcome measures

Mycophenolic acid levels

XMP concentration

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group S (pre-surgical MMF, TMZ)Experimental Treatment3 Interventions

Patients planning to undergo surgery receive MMF PO BID and TMZ PO QD for 5 days prior to surgery in the absence of disease progression or unacceptable toxicity.

Group II: Group 3 (TMZ, MMF, radiation therapy)Experimental Treatment4 Interventions

Patients who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.

Group III: Group 2 (TMZ, MMF, radiation therapy)Experimental Treatment4 Interventions

Patients with unmethylated glioblastoma who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.

Group IV: Group 1 (TMZ, MMF)Experimental Treatment3 Interventions

Patients who have already undergone surgery or biopsy followed by chemoradiation receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate mofetil

FDA approved

Temozolomide

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,027 Total Patients Enrolled

11 Trials studying Glioblastoma

378 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,381 Total Patients Enrolled

323 Trials studying Glioblastoma

23,088 Patients Enrolled for Glioblastoma

Priya U Kumthekar, MDPrincipal InvestigatorNorthwestern University

Media Library

Mycophenolate Mofetil (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05236036 — Phase 1

Glioblastoma Research Study Groups: Group 2 (TMZ, MMF, radiation therapy), Group 1 (TMZ, MMF), Group 3 (TMZ, MMF, radiation therapy), Group S (pre-surgical MMF, TMZ)

Glioblastoma Clinical Trial 2023: Mycophenolate Mofetil Highlights & Side Effects. Trial Name: NCT05236036 — Phase 1

Mycophenolate Mofetil (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236036 — Phase 1

Frequently Asked Questions

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

Are there any slots available for enrolment in this experiment?

"As indicated on clinicaltrials.gov, this medical research project is currently in the process of recruiting applicants. This trial was originally posted on August 8th 2022 and underwent its latest revision on August 22nd 2022."

Answered by AI

What outcomes is this trial attempting to measure?

"The principal objective of this trial, evaluated over a period lasting up to one cycle + 7 days (or 28 days), is to identify the MTD/RP2D for MMF (Group 2). Secondary goals encompass Overall Survival, Progression Free Survival and Frequency of Adverse Events. For OS and PFS, Kaplan-Meier curves will be plotted and log-rank tests employed; while AEs will be documented according to NCI's CTCAE v. 5.0 system. Median values with 95% confidence intervals are also planned to be estimated."

Answered by AI

What possible harmful effects could patients experience when taking Mycophenolate Mofetil?

"Limited data is available to support the safety and efficacy of Mycophenolate Mofetil, which resulted in a score of 1 being assigned."

Answered by AI

How many participants will be taking part in this investigation?

"Affirmative. Details available on clinicaltrials.gov confirm that the current recruitment status of this medical investigation is open; it was posted on August 8th 2022 and updated lastly on August 22nd 2022, with a goal to enroll 60 patients at one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma

2022. "Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236036.

All > Glioblastoma Chicago > Anaplastic Astrocytoma