| Eligibility |
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.
|
