Concurrent Azeliragon With Craniospinal Irradiation

Launched by NYU LANGONE HEALTH · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a medication called Azeliragon when given alongside a treatment known as craniospinal irradiation (CSI) for patients with certain types of brain tumors, specifically those that have spread to the membranes around the brain and spinal cord. The main goal is to see if this combination is safe for patients dealing with solid tumors or high-grade gliomas that have spread in this way. The trial is currently looking for participants aged 18 and older, including both men and women, who are able to receive radiation therapy and have a good performance status, which means they can carry out daily activities without much difficulty.

If you or someone you know is considering participation, eligible patients will need to have specific health criteria met, such as certain blood counts and liver function levels. Participants can expect to receive the study drug along with their radiation treatment and will be monitored closely throughout the trial for any side effects or issues. It’s important to know that this study is at the first stage of testing, meaning it’s primarily focused on ensuring that the treatment is safe to use with the radiation therapy. Before joining, patients will receive detailed information about the study and must provide their consent to participate.

Gender

ALL

Eligibility 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