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

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ClinicalTrials.gov Identifier: NCT01050621
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Dietary Supplement: vitamin C (ascorbic acid) Phase 1 Phase 2

Detailed Description:

Cytotoxic chemotherapy is relatively ineffective for a large proportion of common cancers. Combining redox active molecules with certain chemotherapy regimens could increase their anti-cancer activity or protect host tissues from toxicity with no loss of anti-cancer activity. Research in this area has been advocated by cancer organizations, but previous clinical trials of combination chemotherapy and antioxidant therapy been small, poorly designed, and unsystematic. Appropriate study of this treatment concept requires a systematic, meticulous empirical approach similar to the one used in conventional cytotoxic drug discovery. This is a Phase I-II study designed to identify promising chemotherapy-antioxidant protocols and determine their acceptability and limiting toxicity in patients with relentlessly progressive cancers for which conventional chemotherapy is clinically indicated but is known to be minimally or marginally effective.

The tolerable dose of intravenous ascorbic acid (IVAA) for cancer patients with normal renal function not receiving chemotherapy is 1.5 g/kg per 90 to 120 minute infusion (Hoffer et al, Ann Oncol 2008;19:1969-1974). Side effects are minimal to non-existent. In this dose-escalating study the IVAA will be 0.9 g/kg per infusion for the first chemotherapy cycle, increasing to 1.5 g/kg per infusion in subsequent cycles, for the first 3 participants. If well tolerated as expected, the initial dose will be 1.5 g/kg per infusion for subsequent participants. Infusions will take place 2 or 3 times per week, bracketing the days of chemotherapy. Standard tolerance and adverse effect criteria will be used. Therapy will continue for a minimum of 2 months, and continue further in the event of disease stabilization or response, as determined from CT scan and biomarkers, with evaluations continuing every 2 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Intervention Details:
  • Dietary Supplement: vitamin C (ascorbic acid)
    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

Primary Outcome Measures :
  1. 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. [ Time Frame: At every clinic visit ]
  2. Observe for qualitative indicators that IV ascorbic acid mitigates chemotherapy adverse effects [ Time Frame: Every treatment cycle ]

Secondary Outcome Measures :
  1. To monitor for disease arrest or response (RECIST criteria) in a population in which arrest or response is unusual or rare [ Time Frame: CT assessment every 2 months ]
  2. Quality of life assessment using FACT B and POMS R [ Time Frame: every month ]
  3. Measure the effect of chemotherapy on pharmacokinetics of intravenous ascorbic acid [ Time Frame: Before and 5 days following first chemotherapy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050621

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Canada, Quebec
Clinical Research Unit, Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
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Principal Investigator: Leonard John Hoffer, MD PhD Faculty of Medicine, McGill University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Hoffer, Physician, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01050621    
Other Study ID Numbers: VITC-003
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by John Hoffer, Jewish General Hospital:
ascorbic acid
vitamin C
redox therapy
cytotoxic chemotherapy
Additional relevant MeSH terms:
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Ascorbic Acid
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents