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

NCT01125449 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: L500HD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Adenocarcinoma; Carcinoma; Multiple Myeloma; Desmoplastic Small Round Cell Tumor

Keywords

ascorbic acid; vitamin C; antioxidants; vitamins

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment

  Survival as a result of efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by PET/CT scan interpretation, lab studies and current good clinical practice methodologies for solid tumor interventional treatment.

  12-weeks

Secondary Outcomes (1)

• Patient self-assessment of Quality of Life at 12-weeks

  12-weeks

Study Arms (1)

Intravenous IVC Intervention

OTHER

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

Drug: Ascorbic acid (vitamin C)

Interventions

Ascorbic acid (vitamin C) DRUG

Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.

Also known as: Bioniche ascorbic acid, parenteral, 500mg/ml

Intravenous IVC Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Situs Cancer Research Center: lead

Study Sites (1)

Situs Cancer Research Center

Rogers, Arkansas, 72756, United States

Location

Related Publications (12)

• Mikirova NA, Ichim TE, Riordan NH. Anti-angiogenic effect of high doses of ascorbic acid. J Transl Med. 2008 Sep 12;6:50. doi: 10.1186/1479-5876-6-50.

  PMID: 18789157 BACKGROUND

• Duconge J, Miranda-Massari JR, Gonzalez MJ, Jackson JA, Warnock W, Riordan NH. Pharmacokinetics of vitamin C: insights into the oral and intravenous administration of ascorbate. P R Health Sci J. 2008 Mar;27(1):7-19.

  PMID: 18450228 BACKGROUND

• Duconge J, Miranda-Massari JR, Gonzalez MJ, Taylor PR, Riordan HD, Riordan NH, Casciari JJ, Alliston K. Vitamin C pharmacokinetics after continuous infusion in a patient with prostate cancer. Ann Pharmacother. 2007 Jun;41(6):1082-3. doi: 10.1345/aph.1H654. Epub 2007 May 22. No abstract available.

  PMID: 17519294 BACKGROUND

• Riordan HD, Casciari JJ, Gonzalez MJ, Riordan NH, Miranda-Massari JR, Taylor P, Jackson JA. A pilot clinical study of continuous intravenous ascorbate in terminal cancer patients. P R Health Sci J. 2005 Dec;24(4):269-76.

  PMID: 16570523 BACKGROUND

• Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.

  PMID: 20068072 BACKGROUND

• Levine M, Espey MG, Chen Q. Losing and finding a way at C: new promise for pharmacologic ascorbate in cancer treatment. Free Radic Biol Med. 2009 Jul 1;47(1):27-9. doi: 10.1016/j.freeradbiomed.2009.04.001. Epub 2009 Apr 8. No abstract available.

  PMID: 19361554 BACKGROUND

• Robitaille L, Mamer OA, Miller WH Jr, Levine M, Assouline S, Melnychuk D, Rousseau C, Hoffer LJ. Oxalic acid excretion after intravenous ascorbic acid administration. Metabolism. 2009 Feb;58(2):263-9. doi: 10.1016/j.metabol.2008.09.023.

  PMID: 19154961 BACKGROUND

• Hoffer LJ, Levine M, Assouline S, Melnychuk D, Padayatty SJ, Rosadiuk K, Rousseau C, Robitaille L, Miller WH Jr. Phase I clinical trial of i.v. ascorbic acid in advanced malignancy. Ann Oncol. 2008 Nov;19(11):1969-74. doi: 10.1093/annonc/mdn377. Epub 2008 Jun 9.

  PMID: 18544557 BACKGROUND

• Chen Q, Espey MG, Sun AY, Lee JH, Krishna MC, Shacter E, Choyke PL, Pooput C, Kirk KL, Buettner GR, Levine M. Ascorbate in pharmacologic concentrations selectively generates ascorbate radical and hydrogen peroxide in extracellular fluid in vivo. Proc Natl Acad Sci U S A. 2007 May 22;104(21):8749-54. doi: 10.1073/pnas.0702854104. Epub 2007 May 14.

  PMID: 17502596 BACKGROUND

• Chen Q, Espey MG, Krishna MC, Mitchell JB, Corpe CP, Buettner GR, Shacter E, Levine M. Pharmacologic ascorbic acid concentrations selectively kill cancer cells: action as a pro-drug to deliver hydrogen peroxide to tissues. Proc Natl Acad Sci U S A. 2005 Sep 20;102(38):13604-9. doi: 10.1073/pnas.0506390102. Epub 2005 Sep 12.

  PMID: 16157892 BACKGROUND

• Chen Q, Espey MG, Sun AY, Pooput C, Kirk KL, Krishna MC, Khosh DB, Drisko J, Levine M. Pharmacologic doses of ascorbate act as a prooxidant and decrease growth of aggressive tumor xenografts in mice. Proc Natl Acad Sci U S A. 2008 Aug 12;105(32):11105-9. doi: 10.1073/pnas.0804226105. Epub 2008 Aug 4.

  PMID: 18678913 BACKGROUND

• Ohno S, Ohno Y, Suzuki N, Soma G, Inoue M. High-dose vitamin C (ascorbic acid) therapy in the treatment of patients with advanced cancer. Anticancer Res. 2009 Mar;29(3):809-15.

  PMID: 19414313 BACKGROUND

MeSH Terms

Conditions

Sarcoma; Adenocarcinoma; Carcinoma; Multiple Myeloma; Desmoplastic Small Round Cell Tumor

Interventions

Ascorbic Acid; Injections

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• G D Murphy, MD

  Situs Cancer Research Center

  PRINCIPAL INVESTIGATOR

• J Bolt, PhD

  Situs Cancer Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2010
• First Posted: May 18, 2010
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 18, 2025

Record last verified: 2020-06

Locations

US (1)