GammaTile + Stupp Protocol for Glioblastoma

(GESTALT Trial)

Not currently recruiting at 23 trial locations

Overseen By Sita Patel, PhD, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: GT Medical Technologies, Inc.

Must be taking: Temozolomide

Must not be taking: Anti-cancer medications

Disqualifiers: IDH mutated glioma, Prior chemotherapy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating glioblastoma, an aggressive brain tumor. Researchers aim to determine if adding GammaTile, a special radiation device, during surgery can enhance treatment when combined with the current standard care (the Stupp Protocol). The study seeks to establish whether this combination is safe and does not delay other treatments. Individuals with newly diagnosed glioblastoma who can undergo tumor removal surgery might be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial prohibits the use of other systemic or local anti-cancer medications or treatments, except for TTF (tumor treating fields) before progression. However, anti-angiogenic therapy and steroids are allowed for symptom management. It's best to discuss your specific medications with the trial team to see if they are allowed.

What is the safety track record for GammaTile radiation therapy and the Stupp Protocol?

Research shows that GammaTile radiation therapy is generally safe for treating brain tumors. It uses small collagen tiles containing tiny radiation sources to target cancer cells. Studies have found that GammaTile is well-tolerated and can effectively control tumor growth with few radiation-related side effects.

Temozolomide, a chemotherapy drug, is also part of the treatment plan. Research indicates it is safe and can help improve survival in patients with glioblastoma. Most patients tolerate it well, even with long-term use.

Surgical tumor resection is another part of the treatment. This surgery involves removing as much of the tumor as possible. Studies suggest that this procedure is safe and is commonly used to treat glioblastoma.

Overall, the treatments in this study have a strong safety record in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the GammaTile + Stupp Protocol for glioblastoma because it combines cutting-edge approaches to tackle this aggressive brain cancer. Unlike standard treatments that primarily rely on external beam radiation therapy (EBRT) and chemotherapy with temozolomide, this protocol incorporates GammaTile, a unique form of internal radiation therapy. GammaTile is surgically implanted directly at the tumor site during resection, delivering targeted radiation precisely where it's needed most, potentially improving effectiveness and reducing harm to healthy brain tissue. This innovative combination could offer a new hope for patients by enhancing the precision and potency of glioblastoma treatment.

What evidence suggests that GammaTile radiation therapy implantation could be effective for glioblastoma?

Research has shown that GammaTile radiation therapy, when used with the Stupp Protocol, may be promising for treating glioblastoma (GBM). Two studies found GammaTile safe and effective for treating recurrent GBM, suggesting potential benefits for newly diagnosed cases. In this trial, participants will receive a combination of treatments, including the placement of tiny radiation seeds in the tumor area during surgery to control the tumor more quickly and effectively. Temozolomide, a crucial component of the Stupp Protocol, has improved survival rates in GBM patients, making it a key part of this treatment plan. Together, these elements provide strong evidence for the effectiveness of this combined treatment approach. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with scheduled visits, treatment plan, and laboratory tests

Satisfactory hematology as evidenced by standard pre-surgery labs

I can understand English or Spanish.

Exclusion Criteria

My surgery will be done in stages.

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

My brain tumor has spread into the brainstem or thalamus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Phase

Participants undergo resection and GammaTile implantation

Immediate

1 visit (in-person)

Concomitant Phase

Participants receive external beam radiation therapy (EBRT) and temozolomide (TMZ)

6 weeks

5 visits per week (in-person)

Adjuvant Phase

Participants continue with temozolomide (TMZ) treatment

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• EBRT
• GammaTile radiation therapy implantation
• Surgical tumor resection
• Temozolamide

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental: Resection, GammaTile and Stupp Protocol Experimental Treatment 1 Intervention

Resection, Gamma Tile and Stupp Protocol

EBRT is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Approved in European Union as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others

Who Is Running the Clinical Trial?

GT Medical Technologies, Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Published Research Related to This Trial

GammaTile® (GT) is a promising treatment option for recurrent brain metastases, utilizing a permanent brachytherapy device with cesium 131 seeds to deliver targeted radiation therapy.

The study presents a dosimetric modeling method that could enhance the understanding and effectiveness of GT in treating brain metastases, although specific patient outcomes or data were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Recurrent Brain Metastases Using GammaTile Brachytherapy: A Case Report and Dosimetric Modeling Method. Arsenault, T., Labak, CM., Chaung, K., et al.[2022]

GammaTile, a Cesium-131 source embedded in collagen mesh, allows for a higher biological dose of radiation (60 Gy) to be delivered directly to the surgical bed of recurrent glioblastomas, which may enhance treatment effectiveness compared to traditional external beam radiation.

This case report demonstrates the successful combination of GammaTile with hypofractionated external beam radiation therapy (35 Gy) in a patient with recurrent glioblastoma, showing that it is feasible to optimize radiation delivery without causing excessive dose to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile Brachytherapy Combined With External Beam Radiation Therapy for the Treatment of a Partially Resected Secondary Glioblastoma (WHO Grade 4 IDH-Mutant Astrocytoma): Matching External Beam Dose Gradient to Brachytherapy Dose Fall-Off. Peach, MS., Burke, AM., Jo, J., et al.[2021]

In a study of 22 patients with recurrent glioblastoma treated with GammaTile® brachytherapy after surgery, the treatment showed promising local control rates of 86% at six months and 81% at twelve months, indicating its efficacy in managing tumor recurrence.

The safety profile was acceptable, with only one case of 30-day mortality and a low rate of complications, suggesting that GammaTile® can be a viable option in the multi-modality treatment of recurrent glioblastomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile® brachytherapy in the treatment of recurrent glioblastomas. Gessler, DJ., Neil, EC., Shah, R., et al.[2022]

GammaTile® is a new FDA-cleared device that uses 131Cs radiation seeds embedded in a collagen-based tile to deliver targeted radiation therapy during surgery for glioblastoma, aiming to improve local control of the tumor.

This method of surgically targeted radiation therapy could potentially reduce the recurrence of glioblastomas, which often return near the resection site despite standard treatments like surgery and chemo-radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile®: Surgically targeted radiation therapy for glioblastomas. Gessler, DJ., Ferreira, C., Dusenbery, K., et al.[2021]

In a study of seven patients with recurrent gliomas, GammaTile brachytherapy was found to be safe, with no implant-related postoperative complications reported.

The dosimetry results indicated that six out of seven patients received adequate radiation coverage, suggesting that GammaTile can effectively target recurrent brain tumors while maintaining expected surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile for Gliomas: A Single-Center Case Series. Budnick, HC., Richardson, AM., Shiue, K., et al.[2021]

The ROADS trial is a Phase 3 randomized controlled study comparing the effectiveness of post-surgical stereotactic radiotherapy (SRT) to surgically targeted radiation therapy (STaRT) using GammaTile for patients with newly diagnosed metastatic brain tumors.

This trial aims to determine which treatment method provides better outcomes in terms of safety and efficacy for patients undergoing surgery for metastatic brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials in Progress: ROADS Trial. Weinberg, J.[2022]

GammaTile intracranial brachytherapy, using cesium-131 seeds, was successfully performed during an awake craniotomy in a 50-year-old patient with a glioblastoma, demonstrating the safety and feasibility of this approach.

The procedure allowed for precise tumor resection and custom implantation of the GammaTiles, ensuring effective treatment while preserving critical brain functions, such as speech, due to real-time language mapping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of GammaTile intracranial brachytherapy implanted during awake craniotomy. McClelland, S., Gardner, UG., Le, Y., et al.[2021]

GammaTile® Surgically Targeted Radiation Therapy (STaRT) offers a novel approach to brain tumor treatment by using a bioresorbable tile that delivers radiation while minimizing direct contact with brain tissue, which helps reduce normal brain toxicity.

This therapy has been FDA approved since 2018 for recurrent brain tumors and expanded in 2020 to include newly-diagnosed malignant tumors, with ongoing trials aimed at comparing its efficacy and safety against standard radiation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review. Odia, Y., Gutierrez, AN., Kotecha, R.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05342883

GammaTile and Stupp in Newly Diagnosed GBM

The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol.

2.

gammatile.com

gammatile.com/

GammaTile Radiation Therapy

I've just been thrilled with the outcome. [My doctor] said there's been a lot of success with this type of radiation therapy and I would not really have any ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10834587/

The role of GammaTile in the treatment of brain tumors

These data suggest LC outcomes with surgery and Cs-131 use for brain metastases, GBM, and meningioma seem promising, particularly in the context ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11487344/

Early experience and perioperative risk of GammaTile for ...

Their results showed that 21% of patients had complications from GammaTile; however, only 3.6% were considered serious by the authors.

5.

tandfonline.com

tandfonline.com/doi/full/10.2217/fon-2020-0558

Surgically targeted radiation therapy for glioblastomas

Embedding encapsulated 131Cs radiation emitter seeds in collagen-based tiles significantly lowers the technical barriers associated with traditional ...

6.

gammatile.com

gammatile.com/hcp/clinical-evidence/

Clinical Evidence: Healthcare Providers

GammaTile® clinical evidence: Proven local control (LC) and low rates of radiation necrosis (RN) ; Tumor Type, Brain Mets (Recurrent), Brain Mets (Newly Dx & ...