What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma, such as Temozolomide and radiation therapy, are associated with several side effects. Temozolomide can cause nausea, vomiting, fatigue, and myelosuppression, which includes decreased levels of white blood cells, red blood cells, and platelets. Radiation therapy often leads to fatigue, hair loss, and skin changes at the treatment site. Treatments involving mTOR inhibitors, like those being studied with Metformin, can cause side effects such as mouth sores, fatigue, infections, and metabolic disturbances like hyperglycemia. Combining these treatments may increase the risk of overlapping toxicities, necessitating careful monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including Temozolomide (TMZ), which is commonly used in combination with radiotherapy. Temozolomide is an oral alkylating agent that has shown efficacy in extending survival. While the provided context does not mention specific FDA approvals for drugs that activate AMPK or inhibit mTOR similar to Metformin, it does highlight ongoing research into the potential benefits of Metformin in Glioblastoma treatment due to its low toxicity and promising preliminary results. Other treatments under investigation include tirapazamine, a bioreductive agent, in combination with radiation therapy.

What other types of research exist?

Promising alternatives to Metformin for Glioblastoma patients in 2024 include mTOR inhibitors like everolimus and temsirolimus, potentially in combination with agents like octreotide. Tyrosine kinase inhibitors such as cabozantinib also represent a novel and promising treatment option.

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Metformin and Standard Therapy for Glioblastoma

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

Must not have

Diabetic patients both type I and type II

Margin of contrast-enhanced residual mass closer than 15 mm from the optic chiasm or optic nerves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if Metformin, a diabetes drug, can improve treatment for patients with newly diagnosed aggressive brain cancer (GBM). Metformin, a commonly used drug for the treatment of diabetes, has recently emerged as a promising anticancer molecule. It may help by slowing cancer cell growth and enhancing current treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes, either type 1 or type 2.

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My tumor is near my optic nerves or chiasm.

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I do not have severe health issues that would stop me from completing the study.

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My brain cancer has come back or is in multiple places.

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I am not pregnant and willing to use contraception if of childbearing potential.

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I have had an allergic reaction to Temozolomide or Metformin.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients completing the study treatment

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Glioblastoma include Temozolomide (TMZ) and Metformin. Temozolomide is an oral alkylating agent that works by adding alkyl groups to the DNA of cancer cells, leading to DNA damage and cell death. This is particularly important for Glioblastoma patients as it targets rapidly dividing tumor cells. Metformin, traditionally used for diabetes, activates AMP-activated protein kinase (AMPK) and inhibits the mTOR pathway, which are crucial for cell growth and metabolism. By inhibiting mTOR, Metformin can reduce tumor growth and proliferation, making it a promising adjunct therapy for Glioblastoma. These mechanisms are significant as they offer targeted approaches to disrupt the metabolic and proliferative capabilities of Glioblastoma cells, potentially improving patient outcomes.