Cs-131 Brachytherapy for Recurrent Brain Cancer

Recruiting at 7 trial locations

Overseen By Brandon Imber, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Leptomeningeal carcinomatosis, Immunodeficiency, others

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: Unknown

Duration: Immediate (during surgery)

103 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with recurrent brain cancer. It examines whether adding Cs-131 brachytherapy, a type of radiation treatment applied directly to the brain during surgery, can prevent tumors from returning after removal. The trial compares this method with the usual surgery-only approach to determine which is more effective and safe. Suitable candidates for this trial include those scheduled for brain surgery to remove a previously treated tumor and who can undergo an MRI scan. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cesium-131 brachytherapy is generally safe for treating brain tumors. In past studies, patients tolerated this treatment well, with few serious side effects. One study found that Cesium-131 brachytherapy effectively controlled tumor growth in various brain conditions. Another study confirmed these results, demonstrating its effectiveness for recurring brain tumors, such as glioblastomas and meningiomas.

Overall, evidence suggests that Cesium-131 brachytherapy is a safe option for individuals with recurring brain tumors. Surgeons can use it during procedures to help prevent tumor recurrence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about Cesium-131 brachytherapy for recurrent brain cancer because it offers a targeted approach to treat tumors. Unlike standard treatments that may involve broader radiation, Cesium-131 is implanted directly at the tumor site, delivering high doses of radiation precisely where it's needed while sparing surrounding healthy tissue. This method has the potential to reduce side effects and improve recovery times compared to more conventional radiation therapies. Additionally, combining this approach with a craniotomy allows for immediate treatment following tumor resection, potentially enhancing its effectiveness in controlling cancer growth.

What evidence suggests that Cs-131 brachytherapy might be an effective treatment for recurrent brain cancer?

Research shows that Cesium-131 brachytherapy is a promising treatment for recurrent brain cancer. In this trial, some participants will undergo resection plus brachytherapy, with Cesium-131 implanted during surgery. Studies have found this approach safe and effective for brain tumors that have spread, linking Cesium-131 to slower tumor regrowth in recurring brain tumors like meningiomas and glioblastomas. Another study highlighted its potential benefits in controlling brain tumors while being cost-effective. Additionally, Cesium-131 has FDA clearance, recognizing it as a promising option for certain brain tumors. These findings suggest Cesium-131 could help prevent brain tumors from regrowing after surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Nelson Moss, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent brain cancer who can consent, are able to have an MRI, and are scheduled for brain surgery. They should be in good enough health to perform daily activities (KPS ≥70) and not pregnant or breastfeeding. Excluded are those with infections, immunodeficiency, urgent surgery needs, more than six active brain lesions, intolerance to MRI/CT scans or excessive prior radiation.

Inclusion Criteria

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

I am scheduled for surgery to remove a brain tumor that was previously treated with radiation.

You are able to have a brain MRI with a special dye called gadolinium.

Exclusion Criteria

I do not have an active infection or a weak immune system.

Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)

You can't handle MRI or CT scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo craniotomy with or without Cs-131 brachytherapy during brain surgery

Immediate (during surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and physical examinations

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Cesium-131 brachytherapy
• Craniotomy

Trial Overview The study tests if Cs-131 brachytherapy during brain surgery helps prevent tumor regrowth compared to standard surgery without it. It's a randomized Phase II trial where the effectiveness and safety of adding Cs-131 at the time of tumor removal will be evaluated against usual surgical care.

How Is the Trial Designed?

Group I: Resection plus brachytherapy Experimental Treatment 2 Interventions

Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.

Group II: Resection without brachytherapy Active Control 1 Intervention

Patients will undergo craniotomy.

Cesium-131 brachytherapy is already approved in United States for the following indications:

Approved in United States as Cs-131 brachytherapy for:

• Brain metastases

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

GT Medical Technologies, Inc.

Industry Sponsor

Trials

6

Recruited

1,700+

Published Research Related to This Trial

In a study involving 30 patients, the 'seeds-on-a-string' technique using Cs-131 brachytherapy showed that cavity volume remained stable during treatment, which is crucial for effective radiation delivery.

While Cs-131 patients experienced less cavity shrinkage compared to those receiving stereotactic radiosurgery (SRS) during the first month, no cases of radiation necrosis were reported, indicating a safe application of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Technique and Clinically Relevant Resection Cavity Dynamics Following Implantation of Cesium-131 (Cs-131) Brachytherapy in Patients With Brain Metastases. Wernicke, AG., Lazow, SP., Taube, S., et al.[2019]

In a study of 119 patients treated with Cesium-131 (Cs-131) brachytherapy for CNS tumors, the treatment showed high local control rates, particularly 84.7% for brain metastases and 83.3% for meningiomas, indicating its efficacy across different tumor types.

The safety profile was also favorable, with only 8.4% of patients experiencing radiation necrosis and 11.8% having wound complications, suggesting that Cs-131 brachytherapy is a viable option for managing CNS tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Cesium-131 brachytherapy for brain tumors. Bander, ED., Kelly, A., Ma, X., et al.[2023]

Cesium-131 (Cs) brachytherapy is a safe treatment for patients with resected brain tumors, showing minimal radiation exposure to medical personnel and family members, with most dosimetry badges recording near-zero dose equivalents.

The study found a significant correlation between the number of Cs seeds implanted and the radiation dose rate at the surface, indicating that higher seed counts lead to increased radiation exposure, but still within safe limits according to National Council on Radiation Protection guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Exposure and Safety Precautions Following 131Cs Brachytherapy in Patients with Brain Tumors. Yondorf, MZ., Schwartz, TH., Boockvar, JA., et al.[2022]

In a study involving 18 patients with recurrent brain metastases, cesium-131 (Cs-131) brachytherapy was used effectively, with a median of 16 seeds implanted per patient, demonstrating its potential as a safe adjunct treatment for brain tumors.

Radiation safety measures were established based on real-time dose rate measurements, ensuring minimal exposure for caregivers and the public, with specific precautions recommended for close contact during the first 1-3 weeks post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific radiological protection precautions following Cs collagen embedded Cs-131 implantation in the brain. Prasad, K., Dauer, LT., Chu, BP., et al.[2022]

Cesium-131 brachytherapy has been shown to be a safe and effective treatment for primary and metastatic brain tumors, with a median follow-up of 16.2 months and a high local progression-free rate of 94%.

The treatment resulted in low rates of complications, such as radiation necrosis (3.4%) and seizures (4.7%), indicating that it minimizes radiation-induced side effects while effectively targeting brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cesium-131 brachytherapy in brain tumors: a scoping review of the literature and ongoing clinical trials. Palmisciano, P., Haider, AS., Balasubramanian, K., et al.[2022]

Intraoperative cesium-131 (Cs-131) brachytherapy for patients with recurrent brain metastases after previous radiotherapy showed an impressive 1-year local freedom from progression rate of 83.3%, indicating its efficacy as a salvage treatment.

The treatment was well tolerated, with manageable complications, and resulted in a median overall survival of 7 months, suggesting that Cs-131 brachytherapy is a safe option for patients with previously irradiated tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cesium-131 brachytherapy for recurrent brain metastases: durable salvage treatment for previously irradiated metastatic disease. Wernicke, AG., Smith, AW., Taube, S., et al.[2019]

Permanent cesium-131 brachytherapy implants used after the surgical removal of brain metastases resulted in a 100% local freedom from progression rate, indicating high efficacy in preventing local recurrence without the need for additional therapy.

The treatment was safe and well-tolerated, with minimal complications reported (only 3 cases of CSF leak, seizure, and infection) and no instances of radiation necrosis, suggesting it could be a convenient alternative to traditional whole-brain radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of resection and intraoperative cesium-131 radioisotope brachytherapy in patients with newly diagnosed brain metastases. Wernicke, AG., Yondorf, MZ., Peng, L., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S096758682300019X

Cesium-131 brachytherapy for the treatment of brain ... Cesium-131 brachytherapy is a safe and effective post-surgical treatment option for brain metastases with associated clinical and cost-effectiveness benefits.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9328626/

Salvage resection plus cesium-131 brachytherapy durably ... Initial clinical data using collagen-embedded Cs131 brachytherapy suggest safety and early efficacy for recurrent meningiomas, glioblastomas and ...

3. thejns.org thejns.org/view/journals/j-neurosurg/126/4/article-p1212.xml

Cesium-131 brachytherapy for recurrent brain metastases The authors evaluated the outcomes of this novel treatment with permanent intraoperative Cs-131 brachytherapy. METHODS. Thirteen patients with ...

4. mdpi.com mdpi.com/2072-6694/16/15/2723

Brachytherapy in Brain Metastasis Treatment: A Scoping ... This review explores brachytherapy, a treatment where radioactive sources are placed directly into or near tumors or tumor beds to deliver targeted radiation.

5. brachyjournal.com brachyjournal.com/article/S1538-4721(20)30295-6/fulltext

First clinical implementation of GammaTile permanent brain ... GammaTile cesium-131 ( 131 Cs) permanent brain implant has received Food and Drug Administration (FDA) clearance as a promising treatment for certain brain ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37249824/

Safety and efficacy of Cesium-131 brachytherapy for brain ... Cs-131 brachytherapy demonstrated a favorable safety and efficacy profile characterized by high rates of local control for all treated pathologies.

7. mdpi.com mdpi.com/2673-592X/5/2/13

A Veterinary Case Study with a Review of Clinical Usage ... Resection and Permanent intracranial brachytherapy using modular, biocompatible cesium 131 implants results in 20 recurrent previously irradiated meningiomas.