We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125449
Recruitment Status : Suspended (Awaiting response from FDA as to status of parenteral ascorbic acid manufactured by Bioniche (Ireland).)
First Posted : May 18, 2010
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Situs Cancer Research Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Sarcoma Adenocarcinoma Carcinoma Multiple Myeloma Desmoplastic Small Round Cell Tumor Drug: Ascorbic acid (vitamin C) Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease
Study Start Date : January 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of treatment [ Time Frame: 12-weeks ]
    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 :
  1. Quality of Life [ Time Frame: 12-weeks ]
    Quality of life during treatment will be measured using FACT questionnaires.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125449


Locations
Layout table for location information
United States, Arkansas
Situs Cancer Research Center
Rogers, Arkansas, United States, 72756
Sponsors and Collaborators
Situs Cancer Research Center
Investigators
Layout table for investigator information
Principal Investigator: G D Murphy, MD Situs Cancer Research Center
Study Director: J Bolt, PhD Situs Cancer Research Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Situs Cancer Research Center
ClinicalTrials.gov Identifier: NCT01125449    
Other Study ID Numbers: L500HD
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012
Keywords provided by Situs Cancer Research Center:
ascorbic acid
vitamin C
antioxidants
vitamins
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Desmoplastic Small Round Cell Tumor
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents