NCT05720624

Pharmacodynamic Analyses of Metabolic Agents Following Brain Radiation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the impact of taking drugs (agents) that target altered brain metabolism following standard of care brain radiotherapy. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. However, radiotherapy can also cause harmful effects to normal brain functioning. One drug, called anhydrous enol-oxaloacetate (AEO), has previously been studied in ischemic stroke, Alzheimer's disease, Parkinson's disease, and glioma. Drugs such as AEO may help preserve or restore healthy brain function after brain radiotherapy compared to the standard practice which consists of no drugs.

Detailed description

PRIMARY OBJECTIVE: I. Determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation. SECONDARY OBJECTIVE: I. Assess the safety of study drug(s) as quantified by dose-limiting toxicities. CORRELATIVE RESEARCH OBJECTIVES: I. Investigate the relationship of the global CSF metabolome with magnetic resonance spectroscopy metabolite profile. II. Investigate the relationship between brain radiation dose/volume and metabolic alterations in CSF. III. Investigate the impact of metabolic therapy on early cognitive effects of radiotherapy in patients with brain tumors. IV. Utilize paired blood samples to investigate association between the CSF and systemic metabolome. V. Utilize paired stool samples to investigate association between the blood and CSF metabolome with the gastrointestinal microbiome. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I (EARLY POST-RADIATION): Patients within Cohort I are assigned to 1 of 2 arms. ARM A: Patients receive standard of care therapy. ARM B: Patients receive standard of care therapy and receive AEO orally (PO) two times daily (BID) for 1 month on study. COHORT II (DELAYED POST-RADIATION): Patients within Cohort II are assigned to 1 of 2 arms. ARM A: Patients receive standard of care therapy. ARM B: Patients receive standard of care therapy and receive AEO PO BID for 3 months on study. Patients in all cohorts and arms also undergo magnetic resonance spectroscopy (MRS) imaging, collection of cerebrospinal fluid (CSF), and collection of blood on study.

Conditions

• Malignant Central Nervous System Neoplasm

Interventions

Type	Name	Description
DRUG	Anhydrous Enol-oxaloacetate	Given PO
OTHER	Best Practice	Receive standard of care therapy
PROCEDURE	Biospecimen Collection	Undergo collection of CSF and blood
PROCEDURE	Magnetic Resonance Spectroscopic Imaging	Undergo MRS imaging
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-10-20
• Primary completion: 2025-10-20
• Completion: 2025-10-20
• First posted: 2023-02-09
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study