Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06910761
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 blood and CSF sample collection
  • Craniospinal Irradiation — RADIATION
    Undergo photon-VMAT-CSI
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Lumbar Puncture — PROCEDURE
    Undergo LP
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Ommaya Reservoir Tap — PROCEDURE
    Undergo Ommaya reservoir tap
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Volume Modulated Arc Therapy — RADIATION
    Undergo photon-VMAT-CSI

Study Details

This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (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 and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.

Key Dates

Start date
May 5, 2025
Status verified
Nov 2025
Primary completion
Oct 2, 2028
Completion
Oct 2, 2028

Study Design

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

Arms

  • Experimental: Treatment (Photon-VMAT-CSI)
    Patients undergo photon-VMAT-CSI QD for 10 treatments over 10-20 days (Monday-Friday) in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening and follow-up and undergo collection of blood samples throughout the trial. Patients also undergo LP or Ommaya reservoir tap for CSF sample collection during screening and follow-up.

Primary Outcome Measure

Central nervous system (CNS)-progression free survival [ Time Frame: From start of treatment to CNS relapse, CNS progression, death (from any cause), or last contact, whichever occurs first, assessed up to 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Stephanie M. Yoon
[email protected]
626-873-5241
Stephanie M. Yoon (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Stephanie M. Yoon
[email protected]
626-873-5241
Stephanie M. Yoon (PRINCIPAL_INVESTIGATOR)

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