Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

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Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients ≥ 18 years of age who are capable of giving consent.

- 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.

- Karnofsky Performance Status score (KPS) of ≥70.

- Ability to undergo brain MRI with gadolinium.

Exclusion Criteria:

- Unable to tolerate MRI or CT imaging.

- Pregnancy (patients must have a negative pregnancy test within 30 days of the operation) - Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable) - Diagnosis of leptomeningeal carcinomatosis or >5 additional active or untreated CNS lesions for a total of >6 active lesions.

- Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2.

- Apposition of tumor margin to brainstem or optic apparatus.

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

- Urgent surgery required prior to availability of brachytherapy.

Intraoperative Exclusion Criterion:

- Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04690348
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nelson Moss, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Brain Metastases
Study Website:	View Trial Website

Arms & Interventions

Arms

Active Comparator: Resection without brachytherapy

Patients will undergo craniotomy.

Experimental: Resection plus brachytherapy

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

Interventions

Procedure: - Craniotomy

Craniotomy

Radiation: - Cesium-131 brachytherapy

Intracavitary Cesium-131 brachytherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baptist Health South Florida, Miami 4164138, Florida 4155751

Status

Recruiting

Address

Baptist Health South Florida

Miami 4164138, Florida 4155751, 33143

Site Contact

Yazmin Odia, MD

[email protected]

(786) 596-2000

Henry Ford Hospital, Detroit 4990729, Michigan 5001836

Status