What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as localized radiation delivery using Cs-131 (GammaTile), can lead to several side effects. These include headaches, nausea, vomiting, and fatigue. Radiation therapy, in general, can also cause acute and subacute radiation encephalopathy, manifesting as worsening headaches, focal neurologic symptoms, and cognitive decline. Long-term effects may include radiation necrosis, characterized by brain tissue damage, and leukoencephalopathy, which involves white matter changes in the brain. Chemoradiation, often used in conjunction with radiation, can add side effects such as increased risk of infections, hair loss, and skin irritation at the treatment site.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide, which is often used in conjunction with radiotherapy as part of the Stupp protocol. Additionally, localized radiation delivery methods, such as brachytherapy, have been explored. GammaTile, which uses Cs-131 embedded in bioresorbable collagen tiles for localized radiation delivery, represents a novel approach currently under investigation. This method aims to improve local control and overall survival by initiating radiation at an earlier time point and delivering a rapid dose to the tumor site.

What other types of research exist?

Promising novel alternatives to GammaTile for Glioblastoma patients include: 1) Stereotactic Radiosurgery (SRS) using advanced techniques like Gamma Knife or Proton Beam Therapy, which offer precise radiation delivery to the tumor. 2) Tumor Treating Fields (TTF), which use electric fields to disrupt cancer cell division and have shown efficacy in combination with temozolomide. 3) Immunotherapy approaches, such as checkpoint inhibitors (e.g., pembrolizumab) and CAR-T cell therapy, which are being actively investigated in clinical trials for their potential to enhance the immune response against GBM.

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GammaTile + Stupp Protocol for Glioblastoma (GESTALT Trial)

Phase 4

Recruiting

Research Sponsored by GT Medical Technologies, Inc.

Eligibility Criteria Checklist

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

Must have

Able to receive 5-aminolevulinic acid (5-ALA) or other institutionally standard immunofluorescent-guidance

Karnofsky Performance Scale (KPS) score of ≥ 70

Must not have

Staged surgery planned

Prior invasive malignancy within 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12,18 and 24 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if adding GammaTile radiation therapy to standard treatment can improve outcomes for patients with newly diagnosed GBM. GammaTile delivers quick, direct radiation to the tumor, which may help control the tumor better and improve survival rates.

Who is the study for?

Adults diagnosed with a specific brain cancer called GBM who can undergo surgery to remove the tumor and are able to follow the Stupp protocol (chemotherapy and radiation). They must have good organ function, not be pregnant, agree to use contraception, and cannot have had certain other treatments or conditions that would interfere with the study.

What is being tested?

The trial is testing if adding GammaTile radiation therapy right after surgery for GBM improves outcomes. Patients will receive this new treatment along with standard chemotherapy and radiation (Stupp protocol) to see if it's safe, tolerable, and effective in controlling tumor growth.

What are the potential side effects?

Potential side effects may include typical reactions from brain surgery or radiation such as headaches, swelling at the site of implantation, fatigue from chemotherapy, possible blood disorders like low platelet counts or anemia. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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I can take a special dye for surgery guidance.

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I am able to care for myself but may not be able to do active work.

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I am able to care for myself and perform daily activities.

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My brain tumor is confirmed to be GBM with IDH mutation.

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I am 18 years old or older.

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My brain tumor can potentially be completely removed by surgery.

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I am using effective birth control during and up to 3 months after the study.

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I am not currently taking any other cancer treatments.

Exclusion Criteria

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

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My surgery will be done in stages.

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I have not had any other cancer besides this one in the last 2 years.

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My brain tumor has spread into the brainstem or thalamus.

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I am scheduled for therapy to stop new blood vessels from growing into a tumor.

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My brain tumor is IDH mutated.

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My cancer has spread outside the brain in the last 2 years.

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I have had chemotherapy or radiotherapy for cancer in my head or neck.

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I cannot receive temozolomide with other treatments or as a maintenance therapy.

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I am able to understand the study details and can give informed consent.

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I have more than one tumor that cannot be removed in a single surgery.

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I do not have a severe illness that prevents me from receiving chemotherapy or radiotherapy.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12,18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12,18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12,18 and 24 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

Overall incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events in the safety analysis (ITT) population.

Percentage of patients in the Intent to Treat (ITT) population who were able to start the Concomitant Phase (start is defined as first day of EBRT) between 21 and 35 days postoperatively.

Secondary study objectives

Incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events during each phase (surgical phase, concomitant phase, and adjuvant phase, in both the safety analysis (ITT) and PP populations.

Percentage of patients in the per protocol (PP) population who were able to start the Concomitant Phase (start is defined as first day of EBRT) between 21 and 35 days postoperatively.

Percentage of patients lost to attrition after consenting to participate.

+1 more

Other study objectives

Eastern Cooperative Oncology Group Performance Status Scale

Examine intracranial radiation toxicity outcomes in a population of patients for whom radiobiological modeling was used to combine dose of Cs 131 brachytherapy and EBRT (ITT and PP populations)

Immune Competence

+6 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Resection, GammaTile and Stupp ProtocolExperimental Treatment1 Intervention

Resection, Gamma Tile and Stupp Protocol

0 / 20Eligibility 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 primarily aim to maximize tumor control while minimizing damage to surrounding healthy tissue. Standard treatments include surgical resection, radiation therapy, and chemotherapy. GammaTile therapy, a form of brachytherapy, involves implanting bioresorbable collagen tiles embedded with Cs-131 directly into the surgical cavity. This allows for localized, high-dose radiation delivery immediately post-surgery, targeting residual tumor cells more effectively and reducing the delay before radiation begins. This is crucial for GBM patients as it can potentially improve local control and overall survival by addressing the rapid proliferation of tumor cells more promptly and precisely compared to conventional external beam radiation therapy.