What side effects are associated with this type of intervention?

Common treatments for glioblastoma that involve direct localized delivery to the tumor site, such as intra-tumoral administration of drugs via catheter, often include side effects like headache, scalp pain, and localized infection at the catheter insertion site. Other potential side effects can include neurological deficits depending on the tumor's location and the procedure's invasiveness. Broader treatments like chemotherapy and radiation can cause fatigue, nausea, and hair loss. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide, which is often used in conjunction with radiation therapy. Another notable treatment is bevacizumab, an angiogenesis inhibitor. While these treatments are systemic, there are investigational therapies like MTX110 that focus on direct localized delivery to the tumor site. MTX110 is administered via a catheter directly into the tumor, similar to other local therapies being studied, such as DNX-2401, an oncolytic adenovirus. These approaches aim to maximize the drug concentration at the tumor site while minimizing systemic exposure.

What other types of research exist?

Promising novel alternatives to MTX110 for glioblastoma patients include: 1) Tumor Treating Fields (TTF) - a non-invasive treatment that uses electric fields to disrupt cancer cell division. 2) Convection-enhanced delivery (CED) of therapeutic agents like IL13-PE38QQR, which targets glioblastoma cells specifically. 3) Oncolytic virotherapy, such as DNX-2401, which uses engineered viruses to selectively infect and kill tumor cells. 4) CAR-T cell therapy targeting EGFRvIII, a mutation commonly found in glioblastoma cells.

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Virus Therapy

Intra-tumoral MTX110 for Glioblastoma (MAGIC-G1 Trial)

Phase 1

Waitlist Available

Research Sponsored by Biodexa Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Recurrent glioblastoma

Be older than 18 years old

Must not have

Patients with a history of glioblastoma treatment with nitrosoureas

Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety of MTX110 in patients with recurrent glioblastoma. The drug is delivered directly to the tumor through a catheter to target it more effectively.

Who is the study for?

This trial is for patients with recurrent glioblastoma who are healthy enough for surgery and general anesthesia, have a life expectancy over 3 months, and haven't had certain recent treatments. Excluded are those with specific brain lesions, prior nitrosoureas treatment, inability to undergo MRI, or active treatment for another cancer.

What is being tested?

The study tests the safety of MTX110 when directly administered into the tumor site using a catheter system inserted surgically. The focus is on individuals whose glioblastoma has returned after previous treatments.

What are the potential side effects?

Potential side effects may include complications from surgery or catheter placement, reactions to MTX110 at the tumor site such as inflammation or infection, and general side effects like fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

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

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My brain cancer has come back after treatment.

Exclusion Criteria

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

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I have been treated for glioblastoma with nitrosoureas.

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I am scheduled for or currently receiving a second round of radiation for a returning tumor.

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My tumor is located in the back part of my brain.

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My cancer has not spread to my brainstem, cerebellum, or spinal cord and is not actively growing in these areas.

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I haven't had tumor treating fields therapy in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety of MTX110 administered by CED

Secondary study objectives

Best overall response rate

Progression-free survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: MTX-110 with optional catheter repositioningExperimental Treatment2 Interventions

Weekly dosing of MTX110 via CED until progression. At progression, optional catheter repositioning may occur, followed by continued weekly dosing of MTX110 until next progression/ unacceptable toxicity.

Group II: Cohort A: MTX-110Experimental Treatment2 Interventions

Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.

0 / 6Eligibility 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

Glioblastoma treatments often aim to maximize the direct impact on the tumor while minimizing systemic side effects. MTX110, for instance, is administered directly to the tumor site via a catheter, allowing for high local concentrations of the drug, which can enhance its efficacy and reduce systemic toxicity. This localized delivery is crucial for Glioblastoma patients because it targets the tumor more precisely, potentially improving outcomes and reducing adverse effects compared to systemic chemotherapy. Other common treatments include surgical resection to remove as much of the tumor as possible, radiation therapy to destroy remaining cancer cells, and systemic chemotherapy agents like temozolomide, which work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate. The combination of these treatments aims to control tumor growth, alleviate symptoms, and extend survival.