Vitamin C as an Anti-cancer Drug

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rigshospitalet, Denmark
University of Copenhagen
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01080352
First received: March 3, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer?

Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity.

Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years.

The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival.

This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer.

Primary endpoint:

  • Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions

Secondary endpoints:

  • Bone metastases changes after 12 to 20 weekly vitamin c infusions
  • Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12 to 20 weekly vitamin c infusions
  • RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions
  • RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions

Tertiary endpoints:

  • Pharmacokinetics of vitamin c in the elderly cancer patients

Methods and material:

  • 80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for extension arm)
  • Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks

Condition Intervention Phase
Prostatic Neoplasms
Drug: Ascorbic Acid (Vitamin C)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • PSA changes after 12-20 weeks of treatment [ Time Frame: 12, 20 and 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone metastases changes [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • bALP changes [ Time Frame: 12, 20, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • NTX changes [ Time Frame: 12, 20, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • PINP changes [ Time Frame: 12, 20, 26 and 52 weeks ] [ Designated as safety issue: No ]
  • 8-oxo-guanine changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin C treatment

Each subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c.

5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20.

Drug: Ascorbic Acid (Vitamin C)
60grams of ascorbate given intravenous infusion in 1000ml sterile water.

Detailed Description:

Vitamin C for palliative treatment:

Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients claiming big increases in survival time. The efficacy of the drug is questioned and no randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been made.

Recent results from in vitro and xenograft studies in mice has shown some promise for vitamin c as a cytotoxic agent against cancer cells.

The following parameters are recorded for baseline:

  • Biomarkers (PSA, bALP, NTX, PINP)
  • Routine blood work (hgb, creatinine, p-vitamin c etc.)
  • Radio nucleotide bone scintigraphy
  • Prostate biopsies for later microarray (Affymetrix ST1.0)
  • Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)

These parameters are repeated after treatment, usually after 12 to 26 weeks after the first vitamin c infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Castration resistant metastatic prostate cancer (bony or visceral metastases)
  • Gleason sum > 6
  • PSA > 10 ng/ml
  • ECOG < 3
  • Prior orchidectomy or LHRH antagonist/agonist treatment
  • Must give informed content

Exclusion Criteria:

  • Synchronous active cancer (skin cancer excluded)
  • Prior chemotherapy
  • History of oxalate renal stones
  • Glucose-6-phosphate dehydrogenase deficiency
  • Impaired renal function (creatinine > 200micromoles/L
  • Haemochromatosis
  • Cardiac disease (NYHA > 2, CSS > 2, recent AMI (less than 6 months)
  • Recent major surgery (less than 4 weeks before inclusion and more than 2 days of admittance time)
  • Prior intended curative treatment of prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080352

Locations
Denmark
Departmen of Urology, Copenhagen University Hospital at Herlev
Herlev, DK, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Kari J Mikines, MD, DsMC Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01080352     History of Changes
Other Study ID Numbers: 2008-008692-33
Study First Received: March 3, 2010
Last Updated: May 27, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Prostate cancer
palliative care
antioxidants
ascorbic acid
rna expression

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 18, 2014