Trial of Chemotherapy Plus Intravenous Vitamin C in Patients With Advanced Cancer for Whom Chemotherapy Alone is Only Marginally Effective

NCT01050621 | Completed Phase 1

• 1 other identifier: VITC-003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

ascorbic acid; vitamin C; antioxidants; redox therapy; cytotoxic chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  At every clinic visit

• Observe for qualitative indicators that IV ascorbic acid mitigates chemotherapy adverse effects

  Every treatment cycle

Secondary Outcomes (3)

• To monitor for disease arrest or response (RECIST criteria) in a population in which arrest or response is unusual or rare

  CT assessment every 2 months

• Quality of life assessment using FACT B and POMS R

  every month

• Measure the effect of chemotherapy on pharmacokinetics of intravenous ascorbic acid

  Before and 5 days following first chemotherapy

Interventions

vitamin C (ascorbic acid) DIETARY_SUPPLEMENT

ascorbic acid 1.5 g/kg body weight infused over 90 to 120 minutes two or three times weekly concurrent with standard cytotoxic chemotherapy individually selected for each patient by the treating oncologist on the basis of best current clinical practice

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Clinical Research Unit, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• Hoffer 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Leonard John Hoffer, MD PhD

  Faculty of Medicine, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 15, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

CA (1)