RECRUITING

Concurrent Azeliragon With Craniospinal Irradiation

Conditions

Solid Tumor High-grade Glioma Leptomeningeal Metastasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-19

Study Completion:2031-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06724926

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jonathan Yang, MD, PhD

CONTACT

212-731-6276

Jonathan.Yang@nyulangone.org

Cancer Trials Office

CONTACT

212-263-4432

cancertrials@nyulangone.org

Principal Investigator

Jonathan Yang, MD, PhD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Jonathan Yang, MD, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-19

Study Completion Date2031-01

Study Record Updates

Study Start Date2025-02-19

Study Completion Date2031-01

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumor
High-grade Glioma
Leptomeningeal Metastasis