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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2010

Last Updated Date

August 25, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01125449 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]

Quality of life during treatment will be measured using FACT questionnaires.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sarcoma
Adenocarcinoma
Carcinoma
Multiple Myeloma
Desmoplastic Small Round Cell Tumor

Intervention ^ICMJE

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

Study Arm (s)

Intravenous IVC Intervention

Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.

Intervention: Drug: Ascorbic acid (vitamin C)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01125449

Other Study ID Numbers ^ICMJE

L500HD

Has Data Monitoring Committee

Yes

Responsible Party

Situs Cancer Research Center

Study Sponsor ^ICMJE

Situs Cancer Research Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	G D Murphy, MD	Situs Cancer Research Center
Study Director:	J Bolt, PhD	Situs Cancer Research Center

Information Provided By

Situs Cancer Research Center

Verification Date

August 2012

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

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