Evaluation of Ascorbate-Meglumine Therapeutic for SRS

Enrolling by invitation · Phase 1

Conditions studied: Safety

In brief

Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)

Key facts

Study ID

NCT06433791

Run by

LadeRx LLC

People needed

12

Starts

2024-09-09

Expected to finish

2025-09-09

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Duke Health — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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