Status:
RECRUITING
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: 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 cen...
Eligibility Criteria
Inclusion
- 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 ≥ 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
- 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)
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2028
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06910761
Start Date
May 5 2025
End Date
October 2 2028
Last Update
December 8 2025
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618