Recruiting

Active Surveillance

Sponsor:

UCLA

Code:

NCT07827001

Conditions

Brain Cancer

Brain Cancer Metastatic

Nervous System Cancer

CNS Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Brain Cancer

Brain Cancer Metastatic

Nervous System Cancer

CNS Cancer

Study ID

NCT07827001

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

SingleArm

CNS-Penetrating Systemic Therapy

Primary outcome measure

  • Feasibility of Enrolling Patients [ Time Frame: 1 year ]
  • Feasibility of completing required surveillance imaging [ Time Frame: 1 year ]
  • Feasibility of administering Cognitive Assessments [ Time Frame: 1 year ]
  • Feasibility of administering QOL Questionnaires [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Aaron Simon, MD

1-877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.