Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
NCT ID: NCT06910761
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2025-05-05
2028-10-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the efficacy of photon-VMAT-CSI; assessed by median central nervous system progression free survival (CNS-PFS).
SECONDARY OBJECTIVES:
I. To estimate and assess central nervous system (CNS) response rate, response duration, and overall survival probability.
II. To summarize and assess toxicities including: type, frequency, severity, attribution, time course and duration.
III. To characterize and evaluate patient reported outcomes (PROs), including quality of life (QOL), measures:
IIIa. QOL Questionnaire Brain 20 (European Organization for Research and Treatment of Cancer \[EORTC\]-Quality of Life Questionnaire \[QLQ\]-Brain 20 \[BN20\]); IIIb. Core QOL Questionnaire 30 (EORTC-QLQ-Core 30 \[C30\]); IIIc. Patient reported outcomes measurement information system (PROMIS) for Anxiety; IIId. PROMIS Cognition.
EXPLORATORY OBJECTIVES:
I. To characterize inflammatory markers over time. II. To explore the potential association between inflammatory markers and radiation-related toxicity.
III. To evaluate the potential association between circulating cell-free deoxyribonucleic acid (cfDNA), imaging, and response.
IV. To evaluate possible genomic predictors of CNS progression.
OUTLINE:
Patients undergo photon-VMAT-CSI once daily (QD) for 10 treatments over 10-20 days (Monday-Friday) in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) during screening and follow-up and undergo collection of blood samples throughout the trial. Patients also undergo lumbar puncture LP or Ommaya reservoir tap for cerebrospinal fluid (CSF) sample collection during screening and follow-up.
After completion of study treatment, patients are followed up at 1 month and then every 3 months for up to 1 year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Biospecimen Collection
Undergo blood and CSF sample collection
Craniospinal Irradiation
Undergo photon-VMAT-CSI
Electronic Health Record Review
Ancillary studies
Lumbar Puncture
Undergo LP
Magnetic Resonance Imaging
Undergo MRI
Ommaya Reservoir Tap
Undergo Ommaya reservoir tap
Questionnaire Administration
Ancillary studies
Volume Modulated Arc Therapy
Undergo photon-VMAT-CSI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo blood and CSF sample collection
Craniospinal Irradiation
Undergo photon-VMAT-CSI
Electronic Health Record Review
Ancillary studies
Lumbar Puncture
Undergo LP
Magnetic Resonance Imaging
Undergo MRI
Ommaya Reservoir Tap
Undergo Ommaya reservoir tap
Questionnaire Administration
Ancillary studies
Volume Modulated Arc Therapy
Undergo photon-VMAT-CSI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation
* Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
* Patients with extensive, uncontrolled extracranial systemic disease
* Patients without reasonable systemic treatment options per physician / investigator
* Other clinically significant uncontrolled illness per opinion of physician / investigator
* Patients with a history or evidence of HIV infection (unless on effective anti-retroviral therapy with undetectable viral load based on prior tests within 6 months are eligible for this trial)
* Patients with history or evidence of chronic hepatitis B virus (HBV) infection (unless HBV viral load is undetectable based on prior tests and on suppressive therapy)
* Patients with a history or evidence of hepatitis C virus (HCV) infection unless treated and cured. (Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load based on prior tests)
* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study are eligible for this trial
* Females only: Pregnant or breastfeeding
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Unable to undergo MRI brain and spine with gadolinium contrast
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie M Yoon
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Medical Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephanie M. Yoon
Role: primary
Stephanie M. Yoon
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2025-02015
Identifier Type: REGISTRY
Identifier Source: secondary_id
23911
Identifier Type: OTHER
Identifier Source: secondary_id
23911
Identifier Type: -
Identifier Source: org_study_id