Vitamin C as an Anti-cancer Drug
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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
- 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 |
- PSA changes after 12-20 weeks of treatment [ Time Frame: 12, 20 and 26 weeks ] [ Designated as safety issue: No ]
- 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: | March 2013 |
| Estimated Primary Completion Date: | March 2012 (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 |
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| Contact: Kari J Mikines, MD, DsMC | (+45)38682092 ext 82092 | kami@heh.regionh.dk |
| Contact: Torben K Nielsen, MD | (+45)38689821 ext 89821 | tokjni01@heh.regionh.dk |
| Denmark | |
| Departmen of Urology, Copenhagen University Hospital at Herlev | Recruiting |
| Herlev, DK, Denmark, 2730 | |
| Contact: Kari J Mikines, MD, DMSc (+45)38682092 ext 82092 kami@heh.regionh.dk | |
| Contact: Torben K Nielsen, MD (+45)38689821 ext 89821 tokjni01@heh.regionh.dk | |
| Principal Investigator: Kari J Mikines, MD, DMSc | |
| Sub-Investigator: Martin Hoejgaard, MD | |
| Sub-Investigator: Torben K Nielsen, MD | |
| 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: | September 6, 2011 |
| 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 October 17, 2012
