Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Aaron Benjamin Simon

Description

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.

Official Title

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

Keywords

Brain Cancer, Brain Cancer Metastatic, Nervous System Cancer, CNS Cancer, Brain Neoplasms, Nervous System Neoplasms, Central Nervous System Neoplasms, SingleArm

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07827001
Study Type
Observational [Patient Registry]
Participants
Expecting 12 study participants
Last Updated