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MBM-02 for Glioblastoma

Phase 2
Waitlist Available
Led By Joseph Watson, M.D.
Research Sponsored by Matrix Biomed, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights

Study Summary

This trial is testing whether adding MBM-02 to standard care treatment can improve outcomes and decrease side effects.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 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
Progression Free Survival
Secondary outcome measures
Neutropenia
Overall Survival
Thrombocytopenia
Other outcome measures
Radiation Necrosis

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
Cohort 2 will receive standard of care concomitantly with1400 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1 week run-in with MBM-02 prior to radiotherapy; 6 weeks of radiotherapy and concomitant temozolomide; 4 weeks of rest post-radiotherapy and concomitant temozolomide; and Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.
Group II: Cohort 3Experimental Treatment1 Intervention
Cohort 2 will receive standard of care concomitantly with1400 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1 week run-in with MBM-02 prior to radiotherapy; 6 weeks of radiotherapy and concomitant temozolomide; 4 weeks of rest post-radiotherapy and concomitant temozolomide; and Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.
Group III: Cohort 2Experimental Treatment1 Intervention
Cohort 2 will receive standard of care concomitantly with1200 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1 week run-in with MBM-02 prior to radiotherapy; 6 weeks of radiotherapy and concomitant temozolomide; 4 weeks of rest post-radiotherapy and concomitant temozolomide; and Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.
Group IV: Cohort 1Experimental Treatment1 Intervention
Cohort 1 will receive standard of care concomitantly with1000 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1 week run-in with MBM-02 prior to radiotherapy; 6 weeks of radiotherapy and concomitant temozolomide; 4 weeks of rest post-radiotherapy and concomitant temozolomide; and Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.

Find a Location

Who is running the clinical trial?

Matrix Biomed, Inc.Lead Sponsor
5 Previous Clinical Trials
195 Total Patients Enrolled
MedStar GeorgetownUNKNOWN
Joseph Watson, M.D.Principal InvestigatorGeorgetown University

Frequently Asked Questions

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

Could I potentially be a candidate for this clinical research?

"This trial is looking for 55 patients with glioblastoma between the ages of 35 and 75. Applicants must meet the following criteria: If female and of child bearing potential, must be using an effective birth-control method as described in section 3.5; Be > 35 and ≤ 75 years of age; Be newly diagnosed with glioblastoma multiforme within 4 weeks of open biopsy/resection; If male, no sperm donation for 90 days until after the conclusion of the study; Be able to participate for the full term of the clinical investigation; Have recovered from the effects of surgery, post"

Answered by AI

Are there other instances of MBM-02 being studied in a clinical setting?

"To date, there are 4 ongoing studies involving MBM-02 with none currently in Phase 3. Most of the clinical trials related to MBM-02 are taking place in Bronx, New york; however, research is being conducted at 12 different locations."

Answered by AI

How many people are chosen to participate in this research?

"As of May 3rd, 2021, this clinical trial is not presently enrolling patients. It was first posted on June 1st, 2021. There are 458 other trials for glioblastoma and 4 trials for MBM-02 that are actively recruiting patients if you wish to explore other options."

Answered by AI

Are researchers looking for more participants in this clinical trial?

"As of now, this clinical trial has no active postings for candidates. The original posting was on 6/1/2021 and the most recent update was on 5/3/2021. However, there are presently 458 clinical trials actively searching for patients with glioblastoma and 4 trials for MBM-02 admitting participants."

Answered by AI

Has the FDA cleared MBM-02 for use?

"Given that this is a Phase 2 trial, meaning that while there is some data supporting safety, there is no clinical data yet to support efficacy, our team at Power have given MBM-02 a score of 2 for safety."

Answered by AI

Is this research project investigating participants aged 55 years or older?

"To be eligible for this trial, patients must between 35 and 75 years old. In comparison, there are 36 trials specifically for people under 18 and 435 clinical trials available to patients that are over 65."

Answered by AI

Have similar clinical trials been conducted in the past?

"MBM-02 has a long history of being studied, with the first trial completed in 2019. Sponsored by Matrix Biomed, Inc., this initial study only involved 120 people. Despite its small sample size, MBM-02 received Phase 2 drug approval after the first study in 2019. As of now, there are 4 studies involving MBM-02 across 10 cities and 1 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)
2021. "MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04874506.
~14 spots leftby Apr 2025
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