Actively Recruiting
Concurrent Azeliragon With Craniospinal Irradiation
Led by NYU Langone Health · Updated on 2026-01-02
32
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Single institution study to assess the safety of concurrent Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumor malignancies and high-grade gliomas.
CONDITIONS
Official Title
Concurrent Azeliragon With Craniospinal Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with solid tumor malignancy or high-grade glioma with leptomeningeal metastasis confirmed by imaging or cerebrospinal fluid testing
- Candidates for radiation therapy to treat leptomeningeal metastasis
- Karnofsky Performance Status of 60 or greater
- Male or non-pregnant, non-lactating female aged 18 years or older
- Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L, platelet count of at least 75,000/mm3, and hemoglobin of at least 8 g/dL (support allowed)
- Liver enzymes (AST and ALT) less than or equal to 2.5 times upper normal limit, or up to 5 times if liver metastases present; total bilirubin less than or equal to 1.5 times upper normal limit; creatinine clearance over 30 mL/min
- Signed informed consent form prior to study participation
You will not qualify if you...
- Life expectancy less than 2 months according to investigator
- Unable to complete English quality of life questionnaires
- Extensive systemic disease with refusal of standard treatments
- Unable to undergo MRI of brain and spine with gadolinium contrast
- Previous radiation to treatment site preventing safe planning
- Active uncontrolled bacterial or fungal infection requiring systemic therapy
- Serious medical or psychiatric illness compromising safety or data integrity
- Unwilling or unable to comply with study procedures, including taking oral medication
- Gastrointestinal condition affecting swallowing or absorption
- Females of childbearing potential or males with partners of childbearing potential unwilling to use effective contraception during and for 6 months after treatment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
J
Jonathan Yang, MD, PhD
CONTACT
C
Cancer Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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