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Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer

NCT06518057 · University of Washington
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Official title
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
About this study
OUTLINE: Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients may also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients will undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and principal investigator throughout the study. After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then at the time of CNS disease progression, up to 1 year.
Eligibility criteria
Inclusion Criteria: * Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology * Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases * Patients ≥ 18 years old * Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2 * The patient is able to provide informed consent * Hemoglobin \> 8 g/dL * Absolute neutrophil count \> 1,000/mm * Platelet count \> 100,000/mm * Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT) * Patients with reproductive potential must agree to practice two highly effective contraceptive methods Exclusion Criteria: * Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy * Patients with extensive systemic disease and without reasonable systemic treatment options * Patients who are unable to undergo MRI brain and spine with gadolinium contrast * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances * Gross ventricular disease * Brain metastases within 5 mm of the hippocampal contours not previously treated * Pregnant or lactating women
Study design
Enrollment target: 22 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-03
Estimated completion: 2027-12-30
Last updated: 2025-12-11
Interventions
Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Electronic Health Record ReviewProcedure: Lumbar PunctureProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyRadiation: Proton Beam Craniospinal IrradiationOther: Survey AdministrationRadiation: Volume Modulated Arc TherapyProcedure: Hippocampal-Avoidance Craniospinal Irradiation
Primary outcomes
  • Central nervous system (CNS)-progression free survival (PFS) (Up to 12 months)
Sponsor
University of Washington · other
Contacts & investigators
ContactLia M. Halasz · contact · lhalasz@uw.edu · 206-897-2121
InvestigatorLia M. Halasz · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (2)
University of California San FranciscoNot Yet Recruiting
San Francisco, California, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer · TrialPath