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

This study has suspended participant recruitment.
(Awaiting response from FDA as to status of parenteral ascorbic acid manufactured by Bioniche (Ireland).)
Information provided by (Responsible Party):
Situs Cancer Research Center Identifier:
First received: May 16, 2010
Last updated: August 25, 2012
Last verified: August 2012
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.

Condition Intervention Phase
Multiple Myeloma
Desmoplastic Small Round Cell Tumor
Drug: Ascorbic acid (vitamin C)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease

Resource links provided by NLM:

Further study details as provided by Situs Cancer Research Center:

Primary Outcome Measures:
  • Efficacy of treatment [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    Quality of life during treatment will be measured using FACT questionnaires.

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravenous IVC Intervention
Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.
Drug: Ascorbic acid (vitamin C)
Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.
Other Name: Bioniche ascorbic acid, parenteral, 500mg/ml

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older at time of entry on study
  • Disease extent confirmed and documented by CT scan within 45 days of entry on study
  • normal glucose 6-phosphate dehydrogenase
  • no current calcium oxalate nephrolithiasis with the potential to reduce urinary flow
  • ability to understand the informed consent process and to give informed consent to treatment
  • measurable solid tumor neoplastic disease (using RECIST criteria)
  • life expectancy greater than 8-weeks
  • will agree to undergo central line placement (examples are: port-a-catheter, central venous catheter, percutaneously inserted central catheter [PICC] line placement). Patient or regular caregiver must be able to maintain flush central line as directed by study physician. (Study center will provide periodic site dressing changes as required)
  • Failed curative therapy or patient ineligible for definitive curative therapy
  • Karnofsky performance status of at least 40

Exclusion Criteria:

  • any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
  • use of any nicotine product including nicotine patches/gum
  • unstable angina not well managed with medication
  • history of calcium oxalate stone formation
  • pregnancy or nursing of an infant
  • any psychiatric disorder by history or examination that would prevent completion of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01125449

United States, Arkansas
Situs Cancer Research Center
Rogers, Arkansas, United States, 72756
Sponsors and Collaborators
Situs Cancer Research Center
Principal Investigator: G D Murphy, MD Situs Cancer Research Center
Study Director: J Bolt, PhD Situs Cancer Research Center
  More Information


Responsible Party: Situs Cancer Research Center Identifier: NCT01125449     History of Changes
Other Study ID Numbers: L500HD 
Study First Received: May 16, 2010
Last Updated: August 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Situs Cancer Research Center:
ascorbic acid
vitamin C

Additional relevant MeSH terms:
Desmoplastic Small Round Cell Tumor
Multiple Myeloma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Neoplasms, Plasma Cell
Vascular Diseases
Ascorbic Acid
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents processed this record on May 03, 2016