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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Washington
Study ID
NCT06518057
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Leptomeninges
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo CSF sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and/or CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Proton Beam Craniospinal Irradiation — RADIATION
    Undergo proton CSI
  • Survey Administration — OTHER
    Ancillary studies
  • Volume Modulated Arc Therapy — RADIATION
    Undergo photon VMAT CSI
  • Hippocampal-Avoidance Craniospinal Irradiation — PROCEDURE
    Undergo HA

Study Details

This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.

Key Dates

Start date
Mar 3, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Proton or Photon VMAT CSI)
    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 also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients 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.

Primary Outcome Measure

Central nervous system (CNS)-progression free survival (PFS) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Steve Braunstein (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Lia M. Halasz
[email protected]
206-897-2121
Lia M. Halasz (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Francisco· San Francisco, CAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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