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NCT06910761 · City of Hope Medical Center

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

What this study is about

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).

View original scientific description

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).

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

RADIATION

Craniospinal Irradiation

Undergo photon-VMAT-CSI

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Lumbar Puncture

Undergo LP

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Ommaya Reservoir Tap

Undergo Ommaya reservoir tap

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Volume Modulated Arc Therapy

Undergo photon-VMAT-CSI

Primary outcome measures

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

Will be estimated using the Kaplan-Meier estimator, and its associating 95% confidence limit will be calculated using the logit transformation and the Greenwood variance estimate.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • 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 ≥ 50 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

  • Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy
  • 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)

Where

  • Duarte, California
  • Irvine, California

Collaborators

National Cancer Institute (NCI)

Related conditions & keywords

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the LeptomeningesStage IV Lung Cancer AJCC v8

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations

📊
1 of 35 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Duarte

California

Location available
RECRUITING

Irvine

California

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Leptomeningeal Disease Treatment in Duarte?

Join others in California exploring innovative treatment options through clinical research

Leptomeningeal Disease Treatment Options in Duarte, California

If you're searching for Leptomeningeal Disease treatment in Duarte, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Duarte, Irvine and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Leptomeningeal Disease. All study-related care is provided at no cost to participants.

Local Sites
2 locations in California
Now Enrolling
Up to 35 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Leptomeningeal Disease?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Leptomeningeal Disease

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Leptomeningeal Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06910761. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.