Evaluation of Ascorbate-Meglumine Therapeutic for SRS

• Status: Withdrawn
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chris Lascola, MD; LadeRx LLC
• Collaborator: Duke University

Criteria

Inclusion Criteria:

1. Capable of giving written informed consent to participate in the study before undergoing any screening procedures

2. Age greater than (>) 18

3. Life expectancy of at least 3 months

4. GPA score 0.5 or greater

5. A contrast-enhanced brain MRI scan performed within 2 weeks of study registration

6. Imaging demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases

7. Maximum tumor diameter ≤ 3 cm for the largest lesion

Exclusion Criteria:

1. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma)

2. Metastases in the brain stem, pons or medulla or within 3 mm of optic apparatus (such that some portion of the optic nerve or chiasm would receive >10Gy)

3. Previous whole-brain radiation (previous SRS to or surgical resection of other brain metastases is permitted if more than 3 months prior to the date of enrollment on this protocol.)

4. Pregnancy

5. History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency

6. History of oxalate kidney stones

7. History of iron overload or hemochromatosis

8. History of allergy to ascorbic acid

9. Anuria, dehydration, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated and ascorbic acid has high osmolarity

10. Subjects who are on the following drugs and cannot have a drug substitution:

flecainide, methadone, amphetamines, quinidine, and chlorpropamide; note: high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.

11. Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine.

12. Patients for which MRI is contra-indicated