Recurrent Brain Metastases Clinical Trial
Official title:
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
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.
| Status | Recruiting |
| Enrollment | 76 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 a/ß 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering at Basking Ridge (Consent Only) | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Commack (Consent Only) | Commack | New York |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Memorial Sloan Kettering Monmouth (Consent Only) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | GT Medical Technologies, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | freedom from local progression | With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. | 9 months following surgery | |
| Secondary | wound complications | Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians. | 3 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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