Combining Azeliragon with craniospinal irradiation for treating certain brain tumors
A Phase IB Study to Assess Safety of Concurrent Azeliragon With Craniospinal Irradiation in Patients With Leptomeningeal Metastasis From Solid Tumor Malignancies or High-Grade Gliomas
This study is testing if adding Azeliragon to radiation therapy can help patients with certain brain tumors feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06724926 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of administering Azeliragon concurrently with craniospinal irradiation in patients suffering from leptomeningeal metastasis due to solid tumors or high-grade gliomas. The study is conducted at a single institution, NYU Langone Health, and focuses on patients who are candidates for radiation therapy. Participants must meet specific eligibility criteria, including certain blood counts and performance status, to ensure their safety during the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with solid tumor malignancies or high-grade gliomas that have spread to the leptomeninges and are eligible for radiation therapy.
Not a fit: Patients with lower performance status or those not eligible for radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with leptomeningeal metastasis from aggressive tumors.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches in treating leptomeningeal metastasis have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with solid tumor malignancy or high grade glioma with leptomeningeal metastasis established radiographically and/or through cerebrospinal fluid (CSF) cytology * Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastasis * Patients with Karnofsky Performance Status of 60 or greater. * Male or non-pregnant and non-lactating female and ≥ 18 years of age. * Patients with absolute neutrophil count (ANC) ≥ 1.0 × 109/L, platelet count ≥ 75,000/mm3 (75 × 109/L), and hemoglobin (Hgb) ≥ 8 g/dL. Transfusion or growth factor support is allowed. * Patients with aspartate aminotransferase (AST) \[serum glutamic-oxaloacetic transaminase(SGOT)\], alanine aminotransferase (ALT) \[serum glutamic-pyruvic transaminase (SGPT)\] ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 x ULN is acceptable, total bilirubin ≤ 1.5 × ULN, and estimated creatinine clearance of \> 30 mL/min (per Cockroft-Gault formula). * Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities. Exclusion Criteria: * Patient has a life expectancy, per investigator assessment, of less than 2 months. * Patients unable to complete the English quality of life questionnaires * Patient with extensive systemic disease and who declined standard systemic treatment options * Patient who is unable to undergo magnetic resonance imaging (MRI) brain and spine with gadolinium contrast * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerance * Active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy. * Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity. * Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication. * Patients with a gastrointestinal condition that could interfere with swallowing or absorption. * Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of study drug. * Pregnant or lactating women
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Yang, MD, PhD — NYU Langone Health
- Study coordinator: Jonathan Yang, MD, PhD
- Email: Jonathan.Yang@nyulangone.org
- Phone: 212-731-6276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.