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Metformin and Standard Therapy for Glioblastoma

Q: What kind of illnesses is Metformin commonly prescribed for?

<p>Metformin is regularly employed to treat <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a>, but it can also be useful for treating conditions such as type one diabetes mellitus, diabetic ketoacidosis and polycystic ovary syndrome.</p>

Phase 2

Waitlist Available

Led By George Shenouda, M.D.

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

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

Must have

Adequate bone marrow: ANC ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 10 g/dl

KPS > 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial is for patients with newly diagnosed Glioblastoma Multiforme who will receive Metformin in addition to the standard treatment which is surgery, radiation, and Temozolomide.

Who is the study for?

This trial is for adults with a confirmed diagnosis of GBM in the brain, who have had surgery and are recovering well. They must not have other serious health issues or prior treatments that could interfere, be able to undergo MRI or CT scans, and agree to use contraception if they can have children.Check my eligibility

What is being tested?

The study tests Metformin combined with Temozolomide chemotherapy before and after a shortened course of radiotherapy for GBM treatment. The goal is to see if this approach extends survival while maintaining acceptable levels of side effects.See study design

What are the potential side effects?

Potential side effects include low toxicity from Metformin and typical chemotherapy-related issues like blood cell count changes, fatigue, nausea, and potential infection risks due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

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

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My blood counts meet the required levels for treatment.

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I can care for myself but may need occasional help.

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I have a tissue sample available for MGMT status testing.

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I am 18 years old or older.

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My neurological function is normal or slightly impaired.

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My liver tests are within the required range.

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My brain tumor is confirmed as GBM above the tentorium.

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I've had or will have brain scans before and after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at one year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients completing the study treatment

Secondary outcome measures

To assess toxicity of the regimen

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Registered one arm studyExperimental Treatment1 Intervention

Two weeks of neo-adjuvant Metformin+Temozolomide followed by accelerated hypofractionation using an IMRT technique+TMZ & Metformin followed by TMZ, and Metformin as adjuvant component.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

442 Previous Clinical Trials

159,124 Total Patients Enrolled

2 Trials studying Glioblastoma

50 Patients Enrolled for Glioblastoma

George Shenouda, M.D.Principal InvestigatorRadiation Oncologist

Media Library

Metformin Clinical Trial Eligibility Overview. Trial Name: NCT02780024 — Phase 2

Glioblastoma Research Study Groups: Registered one arm study

Glioblastoma Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT02780024 — Phase 2

Metformin 2023 Treatment Timeline for Medical Study. Trial Name: NCT02780024 — Phase 2

Frequently Asked Questions

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

To what extent is the clinical trial open to recruitment?

"Regrettably, this trial is no longer accepting applicants. It was first made available on March 1st 2015 and last updated August 31st 2022. If you are searching for alternate trials, there currently exist 441 studies inviting patients with glioblastoma and 170 Metformin-related investigations that are open to enrollment."

Answered by AI

Are additional participants being accepted into the experiment at this point in time?

"Unfortunately, this trial is not accepting applicants at the moment. The original posting was on March 1st 2015 and it was last edited in August of 2022. If you're still looking for a medical study to join, there are 441 research sites currently recruiting glioblastoma patients and 170 studies seeking participants who will take Metformin."

Answered by AI

Has Metformin been sanctioned by the Food and Drug Administration?

"Metformin's safety was evaluated to be a 2, as the clinical trial is currently in Phase 2 and there are data points available for its safety but not efficacy."

Answered by AI

Are there other investigations involving Metformin that have been conducted?

"Presently, there are 43 Metformin clinical trials in their concluding phase (Phase 3) together with 170 ongoing studies. The majority of these researches for this medication happen to be based out of Pittsburgh, Pennsylvania; however, 1902 other sites around the globe have been providing patients access to trial related activities."

Answered by AI

What kind of illnesses is Metformin commonly prescribed for?

"Metformin is regularly employed to treat diabetes, but it can also be useful for treating conditions such as type one diabetes mellitus, diabetic ketoacidosis and polycystic ovary syndrome."

Answered by AI

Recent research and studies

Current Topics in Developmental BiologyJournal

Stem Cells in Brain Tumor Development

Alcantara Llaguno, Sheila R., Yuntao Chen, Renée M. McKay, and Luis F. Parada. 2011. “Stem Cells in Brain Tumor Development”. Current Topics in Developmental Biology. Elsevier. doi:10.1016/b978-0-12-380916-2.00002-4.

Molecular Cancer TherapeuticsJournal

Metformin in Cancer Therapy: A New Perspective for an Old Antidiabetic Drug?

Ben Sahra, Issam, Yannick Le Marchand-Brustel, Jean-François Tanti, and Frédéric Bost. 2010. “Metformin in Cancer Therapy: A New Perspective for an Old Antidiabetic Drug?”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-09-1186.

Cell CycleJournal

Metformin Selectively Affects Human Glioblastoma Tumor-initiating Cell Viability

Würth, Roberto, Alessandra Pattarozzi, Monica Gatti, Adirana Bajetto, Alessandro Corsaro, Alessia Parodi, Rodolfo Sirito, et al.. 2012. “Metformin Selectively Affects Human Glioblastoma Tumor-initiating Cell Viability”. Cell Cycle. Informa UK Limited. doi:10.4161/cc.23050.

BmjJournal