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)

99 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.

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.

What data supports the effectiveness of the treatment Cs-131 Brachytherapy for Recurrent Brain Cancer?

Research shows that Cs-131 brachytherapy can provide durable local control of brain tumors that have recurred after previous radiation treatments, with a 1-year local control rate of 83.3% and minimal side effects. This suggests it is a safe and effective option for patients with recurrent brain cancer. ^{1 2 3 4 5}

Is Cs-131 brachytherapy safe for humans?

Research shows that Cs-131 brachytherapy is generally safe for treating brain tumors, with limited radiation exposure to patients, family, and medical staff. Safety measures and guidelines ensure that radiation levels remain low, making it a safe option for brain cancer treatment. ^{2 3 5 6 7}

How is Cs-131 brachytherapy different from other treatments for recurrent brain cancer?

Cs-131 brachytherapy is unique because it involves placing radioactive seeds directly into the brain during surgery, providing targeted radiation to the tumor site. This approach minimizes radiation exposure to surrounding healthy tissue and reduces the risk of radiation-induced complications compared to traditional whole-brain radiotherapy, which is delivered over several days and can cause more side effects. ^{1 2 3 4 6}

Research Team

Nelson Moss, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

You can't handle MRI or CT scans.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 (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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cesium-131 brachytherapy for recurrent brain metastases: durable salvage treatment for previously irradiated metastatic disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The role of cesium-131 brachytherapy in brain tumors: a scoping review of the literature and ongoing clinical trials. [2022]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase I/II study of resection and intraoperative cesium-131 radioisotope brachytherapy in patients with newly diagnosed brain metastases. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Cesium-131 brachytherapy for brain tumors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-specific radiological protection precautions following Cs collagen embedded Cs-131 implantation in the brain. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation Exposure and Safety Precautions Following 131Cs Brachytherapy in Patients with Brain Tumors. [2022]