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Vitamin C as an Anti-cancer Drug

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ClinicalTrials.gov Identifier: NCT01080352
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : March 26, 2015
Sponsor:
Collaborators:
Rigshospitalet, Denmark
University of Copenhagen
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE March 4, 2010
Last Update Posted Date March 26, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
PSA changes after 12-20 weeks of treatment [ Time Frame: 12, 20 and 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2011)
  • Bone metastases changes [ Time Frame: 12, 26 and 52 weeks ]
  • bALP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • NTX changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • PINP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • 8-oxo-guanine changes [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
  • Bone metastases changes [ Time Frame: 26 and 52 weeks ]
  • bALP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • NTX changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • PINP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • PCA-3 changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  • 8-oxo-guanine changes [ Time Frame: 11 and 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin C as an Anti-cancer Drug
Official Title  ICMJE Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
Brief Summary

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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: Ascorbic Acid (Vitamin C)
60grams of ascorbate given intravenous infusion in 1000ml sterile water.
Study Arms  ICMJE 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.

Intervention: Drug: Ascorbic Acid (Vitamin C)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2015)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2010)
80
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01080352
Other Study ID Numbers  ICMJE 2008-008692-33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Copenhagen University Hospital at Herlev
Study Sponsor  ICMJE Copenhagen University Hospital at Herlev
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • University of Copenhagen
Investigators  ICMJE
Principal Investigator: Kari J Mikines, MD, DsMC Copenhagen University Hospital at Herlev
PRS Account Copenhagen University Hospital at Herlev
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP