Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented informed consent of the participant and/or legally authorized representative

⁃ Assent, when appropriate, will be obtained per institutional guidelines

• ≥ 18 years

• Karnofsky performance status (KPS) ≥ 60

• Ability to read and understand English or Spanish for questionnaires, or ability to complete questionnaires using certified interpreter

• Histologically confirmed breast cancer or non-small cell lung cancer

• Leptomeningeal disease established either radiographically and/or CSF cytology

• Absolute neutrophil count (ANC) ≥ 1,000/mm\^3

• Hemoglobin ≥ 8 g/dL

• Platelet ≥ 100,000/mm\^3

• Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula

• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

⁃ If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

• Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy

⁃ Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
City of Hope at Irvine Lennar
RECRUITING
Irvine
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2028-10-02
Participants
Target number of participants: 35
Treatments
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.
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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