NCT01125449

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Situs Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma
• Adenocarcinoma
• Carcinoma
• Multiple Myeloma
• Desmoplastic Small Round Cell Tumor

Interventions

Type	Name	Description
DRUG	Ascorbic acid (vitamin C)	Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2010-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study