Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

At every clinic visit

Safety Issue:

Yes

Principal Investigator

Leonard John Hoffer, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of Medicine, McGill University

Authority:

Canada: Health Canada

Study ID:

VITC-003

NCT ID:

NCT01050621

Start Date:

January 2010

Completion Date:

May 2013

Related Keywords:

  • Cancer
  • ascorbic acid
  • vitamin C
  • antioxidants
  • redox therapy
  • cytotoxic chemotherapy

Name

Location