Ascorbate-Meglumine: Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection
Study summary
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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)
Primary outcome measure(s)
Safety as measured by adverse events — 1 week after receiving study drug with SRS Adverse events will be monitored in patients receiving ascorbate-meglumine during Stereotactic Radiosurgery (SRS)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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