Spots Global Cancer Trial Database for Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease

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Trial Identification

Brief Title: Study of High Dose Intravenous (IV) Ascorbic Acid in Measurable Solid Tumor Disease

Official Title: Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

Study ID: NCT01125449

Conditions

Desmoplastic Small Round Cell Tumor

Interventions

Ascorbic acid (vitamin C)

Study Description

Brief Summary: The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.

Detailed Description: Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. This study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using RECIST criteria. Patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.