Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 28, 2020
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for people with recurrent brain cancer who need surgery to remove their tumors. The researchers want to find out if a type of brachytherapy called Cs-131, which involves placing a small radioactive source in the brain during surgery, can help prevent these tumors from coming back. They will compare the results of this treatment with traditional surgery alone to see which approach is more effective and safe for patients.
To participate in this study, patients need to be at least 18 years old and capable of giving consent. They should be scheduled for surgery to remove a previously treated brain tumor and have a good chance of removing most of it. Some key factors that would exclude someone from joining the trial include being unable to undergo certain imaging tests, being pregnant, or having too many active brain lesions. If eligible, participants can expect to undergo surgery with either the new brachytherapy method or the usual approach, and the researchers will monitor their recovery and any changes in their condition closely.
Gender
ALL
Eligibility 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.
About Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Detroit, Michigan, United States
New York, New York, United States
Middletown, New Jersey, United States
Commack, New York, United States
Miami, Florida, United States
Uniondale, New York, United States
Basking Ridge, New Jersey, United States
Patients applied
Trial Officials
Nelson Moss, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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