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

May 16, 2010
August 25, 2012
January 2011
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01125449 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
Quality of life during treatment will be measured using FACT questionnaires.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sarcoma
  • Adenocarcinoma
  • Carcinoma
  • Multiple Myeloma
  • Desmoplastic Small Round Cell Tumor
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
Intravenous IVC Intervention
Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.
Intervention: Drug: Ascorbic acid (vitamin C)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
30
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125449
L500HD
Yes
Situs Cancer Research Center
Situs Cancer Research Center
Not Provided
Principal Investigator: G D Murphy, MD Situs Cancer Research Center
Study Director: J Bolt, PhD Situs Cancer Research Center
Situs Cancer Research Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP