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Metabolic Agents After Brain Radiotherapy for Brain Cancer
Phase 1
Waitlist Available
Led By Terence C. Burns, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial studies drugs that may help preserve or restore healthy brain function after brain radiotherapy.
Who is the study for?
Adults with brain tumors who've had or will have brain radiation, can swallow tablets, and are expected to live more than 6 months. They must be able to do questionnaires and agree to use dual contraception if of childbearing potential. Excluded are those with recent allergies to study drugs, uncontrolled illnesses affecting safety or compliance, pregnant/nursing women (except Arm B), prisoners, mentally handicapped individuals.Check my eligibility
What is being tested?
This trial tests the drug anhydrous enol-oxaloacetate (AEO) on patients after standard brain radiotherapy for nervous system tumors. It compares AEO's ability to preserve healthy brain function against the usual practice without drugs. Participants will also undergo MR spectroscopic imaging and provide biospecimens.See study design
What are the potential side effects?
Specific side effects of AEO aren't detailed here but may include typical reactions from metabolic agents such as gastrointestinal disturbances, changes in blood sugar levels, fatigue, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the feasibility of completing serial cerebrospinal fluid (CSF) collections for pharmacodynamic analyses.
Secondary outcome measures
Incidence of treatment emergent adverse events (AEs) related to oxaloacetate following brain radiation (Arms B and Future Arms)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort II, Arm B (standard of care therapy, AEO)Experimental Treatment5 Interventions
Patients in Cohort II, Arm B receive standard of care therapy and receive AEO PO BID for 3 months on study. Patients also undergo MRS imaging, collection of CSF, and collection of blood on study.
Group II: Cohort I, Arm B ( standard of care therapy, AEO)Experimental Treatment5 Interventions
Patients in Cohort I, Arm B receive standard of care therapy and receive AEO PO BID for 1 month on study. Patients also undergo MRS imaging, collection of CSF, and collection of blood on study.
Group III: Cohort I, Arm A (standard of care therapy)Active Control4 Interventions
Patients in Cohort I, Arm A receive standard of care therapy. Patients also undergo MRS imaging, collection of CSF, and collection of blood on study.
Group IV: Cohort II, Arm A (standard of care therapy)Active Control4 Interventions
Patients in Cohort II, Arm A receive standard of care therapy. Patients also undergo MRS imaging, collection of CSF, and collection of blood on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,059 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,643 Total Patients Enrolled
Terence C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
321 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on blood thinners but do not have a CSF device implanted.I am willing to give samples and can have an MRI with contrast.I am 18 years old or older.I do not have any illnesses that would make it unsafe for me to participate in the study.I have had brain radiation before (specific to cohort 1).My brain tumor has returned after I had radiation treatment.My doctor expects me to live more than 6 months and I can care for myself.My brain or spinal cord cancer has been confirmed by imaging or biopsy.I am scheduled for or have completed brain radiation with specific dose requirements.I don't have a CSF device and can safely undergo a lumbar puncture.I am not allergic to the drugs used in this study.I agree to use two forms of birth control during and 90 days after the study.I cannot swallow pills or have issues absorbing medication.I am willing to stop taking certain supplements 14 days before the study starts and won't take them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I, Arm A (standard of care therapy)
- Group 2: Cohort I, Arm B ( standard of care therapy, AEO)
- Group 3: Cohort II, Arm A (standard of care therapy)
- Group 4: Cohort II, Arm B (standard of care therapy, AEO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the standard of care therapy, AEO, associated with any risks for Cohort I, Arm B participants?
"Due to the limited amount of safety and efficacy data, Cohort I, Arm B (standard of care therapy, AEO) was ranked as a 1 on our scale from one to three."
Answered by AI
Are there currently openings for this experiment?
"According to clinicaltrials.gov, this particular trial is not seeking new volunteers as it was last updated on January 31st 2023 and initially posted in February 15th 2023. However, 112 other trials are currently recruiting participants across the nation."
Answered by AI
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