Clinical trial · Interventional
Trial of Chemotherapy Plus Intravenous Vitamin C in Patients With Advanced Cancer for Whom Chemotherapy Alone is Only Marginally Effective
Phase I - II Clinical Trial of Combination Conventional Cytotoxic Chemotherapy and Intravenous Vitamin C in Patients With Advanced Cancer or Hematologic Malignancy for Whom Cytotoxic Chemotherapy Alone is Only Marginally Effective
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Concurrent administration of intravenous vitamin C (ascorbic acid, 1.5 g/kg, infused two or three times weekly) together with certain cytotoxic chemotherapy regimens could prove to be an effective treatment for some patients with advanced malignancies for whom existing chemotherapy is usually ineffective. The primary objectives of this study are to identify a tolerable and safe dose of intravenous vitamin C when administered during cytotoxic chemotherapy while attempting to empirically identify specific vitamin C-chemotherapy regimens for which the clinical response is unusually favorable after a minimum of 2 months of therapy, as determined by CT scan and biomarkers, when appropriate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vitamin C (ascorbic acid) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety and tolerability of IV ascorbic acid (IVAA) in target dose of 1500 mg/kg supplementing cytotoxic chemotherapeutic drugs. Standard adverse effect criteria will be used.
- timeFrame
- At every clinic visit
- measure
- Observe for qualitative indicators that IV ascorbic acid mitigates chemotherapy adverse effects
- timeFrame
- Every treatment cycle
Secondary outcomes (3)
- measure
- To monitor for disease arrest or response (RECIST criteria) in a population in which arrest or response is unusual or rare
- timeFrame
- CT assessment every 2 months
- measure
- Quality of life assessment using FACT B and POMS R
- timeFrame
- every month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * must be a resident of Quebec, Canada * documented advanced or metastatic cancer or hematologic malignancy in adults over age 18, with measurable disease * adequate bone marrow, hepatic, renal and cardiac function so as to permit conventional chemotherapy * no current calcium oxalate nephrolithiasis with the potential to reduce urinary flow * life expectancy at least 8 weeks. Exclusion Criteria: * glucose-6-phosphate dehydrogenase deficiency * cancers for which existing chemotherapy offers more than a 33% likelihood of a clinically meaningful response * serum creatinine greater than 175 micromol/L * serious GI diseases * infections * recent major surgery * dementia * altered mental status or other condition that would preclude chemotherapy, including poor functional status.
References
Publications (1)
- DERIVEDHoffer LJ, Robitaille L, Zakarian R, Melnychuk D, Kavan P, Agulnik J, Cohen V, Small D, Miller WH Jr. High-dose intravenous vitamin C combined with cytotoxic chemotherapy in patients with advanced cancer: a phase I-II clinical trial. PLoS One. 2015 Apr 7;10(4):e0120228. doi: 10.1371/journal.pone.0120228. eCollection 2015. PMID 25848948