Evaluation of Ascorbate-Meglumine Therapeutic for SRS
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)
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)
Additional locations may be listed on ClinicalTrials.gov for NCT06433791.
Locations matching your search criteria
United States
North Carolina
Durham
Phase 1, single-center, open-label study in subjects receiving Stereotactic Radiosurgery
(SRS) for brain metastases. The study will consist of 4 principal cohorts (n=3 in each
cohort). Each cohort will receive an escalating dose of ascorbate-meglumine as an
Magnetic Resonance Imaging (MRI)-detectable adjunctive therapeutic to SRS.
Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine
penta-acetic acid (GD-DPTA) per standard of care for SRS. Forty-eight hours after the
planning MRI, the subjects will complete the study MRI with ascorbate-meglumine contrast
agent. Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous
administration over 1 hour during the MRI. The total dose of ascorbate-meglumine will
escalate from the first cohort to the next cohort in a sequential manner. During
ascorbate-meglumine infusion, MRI scans will be performed to evaluate the contrast effect
and PK blood draws will occur at defined time points.
Patients will return for the SRS procedure within 1 week following the planning MRI per
standard of care. During SRS, subjects will receive a second dose of ascorbate-meglumine
as an adjunctive therapeutic.
Patients will enter into a follow up phase within 2 weeks after the SRS procedure per
standard of care.
The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a
MRI-detectable adjunctive therapeutic to SRS.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationLadeRx LLC
Principal InvestigatorJohn Paxton Kirkpatrick
- Primary IDLadeRX
- Secondary IDsNCI-2024-07499
- ClinicalTrials.gov IDNCT06433791