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A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy

This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.

Study Overview

• Status: Recruiting
• Conditions: Brain Cancer; CNS Cancer; Nervous System Cancer; Brain Cancer Metastatic

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Aaron Simon, MD; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with brain metastases undergoing CNS-penetrating systemic therapy

Description

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
• Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
• Patients must have no active brain metastasis >3cm in size.
• Leptomeningeal disease is permitted
• Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
• Patients must have no symptoms attributable to active brain metastases.
• At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
• Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
• Must be age ≥ 18 years.
• Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
• Performance status: KPS performance status ≥50%.
• Life expectancy of ≥3 months.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
• Patients with active symptomatic brain metastases.
• Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
• Patients with conditions that exclude them from undergoing magnetic resonance imaging.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SingleArm; CNS-Penetrating Systemic Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Enrolling Patients	Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.	1 year
Feasibility of completing required surveillance imaging	Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.	1 year
Feasibility of administering Cognitive Assessments	Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..	1 year
Feasibility of administering QOL Questionnaires	Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pre-defined safety events	Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy	1 year

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Aaron Simon, MD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 13, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: STUDY00001311; UCI 25-197 (Other Identifier: UCI CFCCC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be shared as a condition for publication of study results in ICMJE journals

Drug and device information, study documents

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