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Trial record 1 of 1 for:    01080352
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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Ascorbic Acid (Vitamin C) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. PSA changes after 12-20 weeks of treatment [ Time Frame: 12, 20 and 26 weeks ]

Secondary Outcome Measures :
  1. Bone metastases changes [ Time Frame: 12, 26 and 52 weeks ]
  2. bALP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  3. NTX changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  4. PINP changes [ Time Frame: 12, 20, 26 and 52 weeks ]
  5. 8-oxo-guanine changes [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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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): NCT01080352


Locations
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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
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Principal Investigator: Kari J Mikines, MD, DsMC Copenhagen University Hospital at Herlev
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01080352    
Other Study ID Numbers: 2008-008692-33
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Copenhagen University Hospital at Herlev:
Prostate cancer
palliative care
antioxidants
ascorbic acid
rna expression
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents