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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Brain Metastases
• Intervention / Treatment: Procedure: Craniotomy; Radiation: Cesium-131 brachytherapy

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brandon Imber, MD; Phone Number: 631-212-6346
• Study Contact Backup: Name: Nelson Moss, MD; Phone Number: 212-639-7075; Email: mossn@mskcc.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
      • Henry Ford Hospital
      • Contact: Adam Robin, MD; Phone Number: 800-436-7936
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering at Basking Ridge (Consent only)
      • Contact: Nelson Moss, MD; Phone Number: 212-639-7075
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Consent only)
      • Contact: Nelson Moss, MD; Phone Number: 212-639-7075
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Commack (Consent only)
      • Contact: Nelson Moss, MD; Phone Number: 212-639-7075
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Brandon Imber, MD; Phone Number: 631-212-6346
      • Contact: Nelson Moss, MD; Phone Number: 212-639-7075
      • Principal Investigator: Nelson Moss, MD
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Nelson Moss, MD; Phone Number: 212-639-7075

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resection without brachytherapy; Patients will undergo craniotomy.	Procedure: Craniotomy; 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.	Procedure: Craniotomy; Craniotomy; Radiation: Cesium-131 brachytherapy; Intracavitary Cesium-131 brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: GT Medical Technologies, Inc.
• Investigators: Principal Investigator: Nelson Moss, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Brain Metastasis; Cs-131 Brachytherapy; 20-542
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Recurrence; Brain Neoplasms
• Other Study ID Numbers: 20-542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes