Pharmacodynamic Analyses of Metabolic Agents Following Brain Radiation
- Conditions
- Malignant Central Nervous System Neoplasm
- Registration Number
- NCT05720624
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age >= 18 years.<br><br> - Radiographic evidence or histopathologic confirmation of central nervous system<br> (CNS) malignancy, with or without prior resection.<br><br> - Planned (cohort 1) or completed (cohort 2) fractionated brain radiation. The<br> therapeutic brain radiation treatment volume should exceed 30 cubic cm, including<br> the volume of brain tissue occupied by infiltrative disease. Volume occupied by<br> solid non-infiltrative disease (e.g. meningioma, metastatic disease, cystic cavity,<br> resection cavity), should be excluded from the estimated treatment volume.<br><br> - Provide written informed consent for the current study and the Neuro-oncology<br> biorepository for archiving of CSF and blood samples collected on this protocol.<br><br> - Expected survival >6 months and Karnofsky performance status >= 60.<br><br> - Willing and able to adhere with the protocol for the duration of the study including<br> undergoing treatment and scheduled visits, and examinations.<br><br> - Alanine aminotransferase (ALT) and aspartate transaminase (AST) <3 x upper limit of<br> normal (ULN) (=< 5 x ULN for patients with baseline liver disease).<br><br> - Serum creatinine =< 1.5 mg/dL.<br><br> - Ability to complete questionnaire(s) by themselves or with assistance.<br><br> - Willingness to provide mandatory CSF and blood and able to undergo magnetic<br> resonance spectroscopy (MRS)/magnetic resonance imaging (MRI) with gadolinium.<br><br> - Male and female patients of childbearing potential must agree to use a dual method<br> of contraception (a highly effective method of contraception in conjunction with<br> barrier contraception) consistently and correctly from the first dose of study drug<br> (Arm B only) until 90 days after the last dose of study drug.<br><br>Exclusion Criteria:<br><br> - Uncontrolled and/or intercurrent illness which limits safety of or compliance to<br> study proceedings.<br><br> - Vulnerable populations: pregnant or nursing women (Arm B exempt), prisoners,<br> mentally handicapped.<br><br> - Patients with recurrent brain tumor after prior radiation.<br><br> - Cohort 1 only: History of prior brain radiation, with prior cumulative target<br> radiation treatment volume exceeding 2 cubic centimeters.<br><br> - Patients who do not have an implanted CSF access device (who would thus require<br> multiple lumbar punctures [LPs] for participation) should be excluded if they have<br> any contra-indication to lumbar puncture. This includes but is not limited to<br> obstructive hydrocephalus or posterior fossa mass or cerebral edema that could<br> increase the risk of brain herniation.<br><br> - Patients who do not have an implanted CSF device and are on anti-platelet therapy<br> (other than Aspirin which is considered low risk) or anticoagulation (coumadin,<br> Eliquis) must discontinue these prior to each lumbar puncture to participate.<br> Patients unwilling or unable to safely do so should not be enrolled.<br><br> - Participants who are unable to swallow tablets or who are at risk for impaired<br> absorption of oral medication. NOTE: This includes but not limited to, refractory<br> vomiting, gastric resection/bypass, and duodenal/jejunal resection.<br><br> - Patients with recent (<3 months [mo]) administration of, or known hypersensitivity<br> or allergy to any active study drug currently available for randomization (initially<br> oxaloacetate).<br><br> - Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain<br> triglyceride-containing (i.e. Axona) supplements, or curcumin will be excluded<br> unless willing to discontinue them 14 days prior to the start of baseline visits and<br> remain off for study duration.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the feasibility of completing serial cerebrospinal fluid (CSF) collections for pharmacodynamic analyses.
- Secondary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (AEs) related to oxaloacetate following brain radiation (Arms B and Future Arms)