Brain radiation recovery drug study halted before start
NCT ID NCT05720624
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if a drug called AEO could help protect brain function after radiation therapy for brain cancer. It planned to collect spinal fluid samples from adult patients to measure brain metabolism. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Started
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Oct 2025
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>= 18 years. * Radiographic evidence or histopathologic confirmation of central nervous system (CNS) malignancy, with or without prior resection. * Planned (cohort 1) or completed (cohort 2) fractionated brain radiation. The therapeutic brain radiation treatment volume should exceed 30 cubic cm, including the volume of brain tissue occupied by infiltrative disease. Volume occupied by solid non-infiltrative disease (e.g. meningioma, metastatic disease, cystic cavity, resection cavity), should be excluded from the estimated treatment volume. * Provide written informed consent for the current study and the Neuro-oncology biorepository for archiving of CSF and blood samples collected on this protocol. * Expected survival \>6 months and Karnofsky performance status \>= 60. * Willing and able to adhere with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) \<3 x upper limit of normal (ULN) (=\< 5 x ULN for patients with baseline liver disease). * Serum creatinine =\< 1.5 mg/dL. * Ability to complete questionnaire(s) by themselves or with assistance. * Willingness to provide mandatory CSF and blood and able to undergo magnetic resonance spectroscopy (MRS)/magnetic resonance imaging (MRI) with gadolinium. * Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug (Arm B only) until 90 days after the last dose of study drug. Exclusion Criteria: * Uncontrolled and/or intercurrent illness which limits safety of or compliance to study proceedings. * Vulnerable populations: pregnant or nursing women (Arm B exempt), prisoners, mentally handicapped. * Patients with recurrent brain tumor after prior radiation. * Cohort 1 only: History of prior brain radiation, with prior cumulative target radiation treatment volume exceeding 2 cubic centimeters. * Patients who do not have an implanted CSF access device (who would thus require multiple lumbar punctures \[LPs\] for participation) should be excluded if they have any contra-indication to lumbar puncture. This includes but is not limited to obstructive hydrocephalus or posterior fossa mass or cerebral edema that could increase the risk of brain herniation. * Patients who do not have an implanted CSF device and are on anti-platelet therapy (other than Aspirin which is considered low risk) or anticoagulation (coumadin, Eliquis) must discontinue these prior to each lumbar puncture to participate. Patients unwilling or unable to safely do so should not be enrolled. * Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication. NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection. * Patients with recent (\<3 months \[mo\]) administration of, or known hypersensitivity or allergy to any active study drug currently available for randomization (initially oxaloacetate). * Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (i.e. Axona) supplements, or curcumin will be excluded unless willing to discontinue them 14 days prior to the start of baseline visits and remain off for study duration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.