A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Phase 2 Active not recruiting 43 enrolled Joseph J. Cullen, MD, FACS Holden Comprehensive Cancer Center · collab National Cancer Institute (NCI) · collab National Institutes of Health (NIH) · collab

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

Timeline

Start: 2018-11-16
Primary completion: 2025-07-15
Completion: 2027-12-31

Publications

Background Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vitamin C	Other / unclassified	75 g	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	45 mg/m2	Intravenous

A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Summary

Timeline

Publications

Drugs

Indications