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).)
Sponsor:
Information provided by (Responsible Party):
Situs Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01125449
First received: May 16, 2010
Last updated: August 25, 2012
Last verified: August 2012
  Purpose

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
Sarcoma
Adenocarcinoma
Carcinoma
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01125449

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

Publications:

Responsible Party: Situs Cancer Research Center
ClinicalTrials.gov 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
antioxidants
vitamins

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Adenocarcinoma
Desmoplastic Small Round Cell Tumor
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Sarcoma
Neoplasms, Connective and Soft Tissue
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014