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Brachytherapy

Cs-131 Brachytherapy for Recurrent Brain Cancer

Phase 2

Recruiting

Led By Nelson Moss, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status score (KPS) of ≥70

Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (≥95%) resection

Must not have

Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency

Urgent surgery required prior to availability of brachytherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months following surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether Cs-131 brachytherapy, administered during brain surgery, can help prevent brain tumors from recurring. The safety and effectiveness of Cs-131 will be compared to the standard of care, brain surgery without brachytherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include risks associated with craniotomy such as infection or bleeding at the site of operation. Specific side effects from Cs-131 brachytherapy could involve localized radiation effects like swelling or damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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

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I need surgery urgently before brachytherapy can be done.

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I have been diagnosed with cancer spread to the lining of the brain or have more than 6 active brain lesions.

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I have received radiation over 100 Gy to the area where the implant will be placed.

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My tumor is close to my brainstem or optic nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months following surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

freedom from local progression

Secondary study objectives

wound complications

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Resection plus brachytherapyExperimental Treatment2 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 brachytherapyActive Control1 Intervention

Patients will undergo craniotomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Craniotomy

2016

N/A

~740

0 / 7Eligibility criteria met