What is the mechanism of action of this treatment?

Glioblastoma (GBM) treatment typically involves a combination of surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing the tumor burden. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, targeting residual cancer cells post-surgery. Chemotherapy, such as temozolomide, works by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted radioembolization therapy, like TheraSphere GBM, involves delivering radioactive particles directly to the tumor site, maximizing the radiation dose to cancer cells while minimizing exposure to surrounding healthy tissue. This targeted approach is crucial for GBM patients as it offers a potential for more effective treatment with fewer side effects, improving quality of life and potentially extending survival.

What side effects are associated with this type of intervention?

Common treatments for glioblastoma include radiotherapy, chemotherapy, and targeted therapies. Radiotherapy can cause acute and subacute radiation encephalopathy, leading to headaches, focal neurologic symptoms, and nausea. Chemotherapy agents like temozolomide are associated with headaches in about 20% of patients. Targeted radioembolization therapy, similar to TheraSphere GBM, may involve side effects such as headache, scalp pain, and feeling cold. These treatments aim to manage tumor growth but can have varying degrees of adverse effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral chemotherapy drug, and bevacizumab, an anti-angiogenic therapy. Temozolomide is often used in combination with radiation therapy, while bevacizumab targets vascular endothelial growth factor (VEGF) to inhibit tumor blood vessel growth. Although specific FDA approvals for targeted radioembolization therapy like TheraSphere GBM are not detailed, these treatments represent the broader landscape of Glioblastoma management.

What other types of research exist?

Promising novel alternatives to TheraSphere GBM for Glioblastoma patients include: 1) Ivosidenib, a mutant-IDH1 inhibitor, which has shown promise in clinical trials for IDH1-mutant gliomas. 2) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III testing for IDH1/2-mutant gliomas. 3) Bevacizumab, an anti-VEGF antibody, which has been used as an alternative to glucocorticoids for managing symptomatic edema in glioblastoma. 4) Investigational IDH-targeted approaches, including small molecule inhibitors and vaccine strategies, which are in various stages of clinical trials.

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Brachytherapy

TheraSphere for Recurrent Brain Cancer (FRONTIER Trial)

Phase < 1

Recruiting

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

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

Must have

Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria

Prior cranial radiation dose < 66 Gy

Must not have

Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe or feasible vascular access or an eloquent high-risk vascular distribution of the treatment plan

Have received more than 2 surgical GBM-related procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through 6 months post index procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiation treatment using tiny radioactive beads for patients with aggressive brain cancer that has come back. The treatment aims to target the tumor more precisely and reduce side effects compared to standard treatments. GammaTile is a device that uses cesium-131 radiation-emitting seeds embedded in a collagen tile to provide targeted radiation therapy for brain tumors.

Who is the study for?

This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment but not more than one round of radiotherapy or two surgeries. They must have adequate organ function, a life expectancy of at least 12 weeks, and be able to follow the trial procedures. Pregnant women can't participate, and those who can bear children must use birth control.

What is being tested?

The FRONTIER Study is testing TheraSphere GBM's safety and feasibility in patients with recurrent glioblastoma. It's an interventional study where participants receive this device to see if it's safe and technically possible to use as a treatment option.

What are the potential side effects?

While specific side effects are not listed for TheraSphere GBM, similar treatments may cause headaches, nausea, fatigue, bleeding or infection at the catheter site; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

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

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My scans show my tumor has grown and is 1 to 5 cm in size.

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I received less than 66 Gy of radiation to my brain.

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I can take care of myself but might not be able to do heavy physical work.

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It has been long enough since my last cancer treatment to start a new one.

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I've been on a stable or reducing steroid dose, not more than 6 mg of dexamethasone daily, for the last week.

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My brain lesion can be safely treated with TheraSphere GBM through microcatheter.

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I have been diagnosed with glioblastoma according to the latest standards.

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My brain treatment area is small and not in the part that controls vital functions.

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I've had surgery and was treated with both radiation and chemotherapy, possibly including Tumor Treating Fields.

Exclusion Criteria

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

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I have serious blood vessel issues that make certain medical procedures unsafe for me.

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I have had more than 2 surgeries for my brain tumor.

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I have had radiation therapy to the chest area before.

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I have had more than one round of radiation therapy to my head.

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I have had treatment directly into the arteries in my brain.

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I have had a stroke or am at risk of brain swelling.

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I have undergone a specialized form of radiation treatment.

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I cannot have an MRI with contrast due to medical reasons.

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I have epilepsy that is not well-controlled.

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My brain tumor is in a critical area or has spread beyond the brain.

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I have undergone more than 2 different systemic cancer treatments.

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I have a severe illness that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through 6 months post index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through 6 months post index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 6 months post index procedure for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).

Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).

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: TreatmentExperimental Treatment1 Intervention

The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

0 / 21Eligibility 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 (GBM) treatment typically involves a combination of surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing the tumor burden. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, targeting residual cancer cells post-surgery. Chemotherapy, such as temozolomide, works by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted radioembolization therapy, like TheraSphere GBM, involves delivering radioactive particles directly to the tumor site, maximizing the radiation dose to cancer cells while minimizing exposure to surrounding healthy tissue. This targeted approach is crucial for GBM patients as it offers a potential for more effective treatment with fewer side effects, improving quality of life and potentially extending survival.