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NCT06433791

Evaluation of Ascorbate-Meglumine Therapeutic for SRS

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
LadeRx LLC
~12 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Ascorbate-Meglumine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as measured by adverse events
Measured over 1 week after receiving study drug with SRS

Conditions

Safety

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Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • John Kirkpatrick, MD · PRINCIPAL_INVESTIGATOR · Duke Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Primary cancer diagnosis with newly diagnosed brain metastases
Diagnostic MRI demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases.
Maximum tumor diameter ≤ 2.5 cm for the largest lesion determined during the planning MRI
Plan of care must include Stereotactic Radiosurgery (SRS)
SRS treatment plan must be delivered as a single RT fraction
Age 18 years and older
Life expectancy of at least 3 months
GPA score 0.5 or greater
Capable of providing written informed consent to participate in the study

Exclusion

Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma)
Metastases in the brain stem, pons or medulla or within 3 mm of the optic apparatus (such that some portion of the optic nerve or chiasm would receive a radiation dose \> 10 Gy SRS in one single fraction)
Previous whole-brain radiation (previous SRS to or resection of other brain lesions is permitted if more than 3 months prior to the date of enrollment on this protocol)
Pregnancy
History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency
History of oxalate kidney stones
History of iron overload or hemochromatosis
History of allergy to ascorbic acid
Anuria, dehydration, serum albumin \<3.0 g/dL, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated .
Subjects who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide.
Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine.
Subjects for which MRI is contra-indicated (for example a pacemaker/recent surgery with orthopedic prosthesis)

What this trial measures

  • Safety as measured by adverse events1 week after receiving study drug with SRS

    Adverse events will be monitored in patients receiving ascorbate-meglumine during Stereotactic Radiosurgery (SRS)