Urinary Excretion of Acetylamantadine by Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
BioMark Technologies Inc.
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00755898
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 18, 2008
September 18, 2008
December 2003
June 2008   (final data collection date for primary outcome measure)
Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a single oral dose of amantadine hydrochloride ingested two hours after supper [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Urinary Excretion of Acetylamantadine by Cancer Patients
Urinary Excretion of Acetylamantadine by Cancer Patients

The investigators have determined that the drug amantadine hydrochloride is metabolized by acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This enzyme is increased in cancer cells. The investigators hypothesized that the amount of N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve as a diagnostic biomarker for the presence of cancer in a human test subject.

When patients present to their physician with symptoms of cancer at a later stage of development, survival tends to be poorer. Earlier diagnosis of cancer is expected to provide improved survival of patients due to earlier treatment intervention. However, implementation of this screening process is impaired by access and by cost. A simple and inexpensive test would serve as a screening tool that could be safely repeated at regular intervals to identify persons for whom more expensive and less accessible diagnostic investigations might become more appropriately directed. The specificity for an enzyme that increases markedly in cancer tissue, and the ease of administration of an already licensed pharmaceutical prescription product, amantadine hydrochloride, would appear to provide promise of such a desirable screening test.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cancer
  • Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
    Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.
  • Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
    Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper
  • Active Comparator: 1
    Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
    Intervention: Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
  • Active Comparator: 2
    Healthy adult volunteers
    Intervention: Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Either a medical diagnosis of cancer, or determination of general good health after a medical check-up within two weeks of participation in the study

Exclusion Criteria:

  • Allergy to amantadine hydrochloride
  • Chronic liver or kidney disease
  • Chronic disease state not controlled by drug therapy, e.g. hypertension
  • Pregnancy
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00755898
B2003:089
No
Daniel S. Sitar, PhD, University of Manitoba
University of Manitoba
  • Canadian Institutes of Health Research (CIHR)
  • BioMark Technologies Inc.
Principal Investigator: Daniel S Sitar, PhD University of Manitoba
University of Manitoba
September 2008

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