Clinical trial · Interventional
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
NCT01125449CI-TRIAL-00089859withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Awaiting response from FDA as to status of parenteral ascorbic acid manufactured by Bioniche (Ireland).
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Desmoplastic Small Round Cell Tumor | Desmoplastic Small Round Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic acid (vitamin C) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Intravenous IVC Intervention
- description
- Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.
- interventionNames
- Drug: Ascorbic acid (vitamin C)
Primary outcomes (1)
- measure
- Efficacy of treatment
- timeFrame
- 12-weeks
- description
- 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.
Secondary outcomes (1)
- measure
- Patient self-assessment of Quality of Life at 12-weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDMikirova 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
- BACKGROUNDDuconge 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
- BACKGROUNDDuconge 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
- BACKGROUNDRiordan 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
- BACKGROUNDDu 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
- BACKGROUNDLevine 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
- BACKGROUNDRobitaille 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.