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Urinary Excretion of Acetylamantadine by Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755898
First Posted: September 19, 2008
Last Update Posted: September 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
BioMark Technologies Inc.
Information provided by:
University of Manitoba
  Purpose
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.

Condition Intervention Phase
Cancer Drug: Ingestion of a 200 mg dose of amantadine hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urinary Excretion of Acetylamantadine by Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: December 2003
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
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.
Active Comparator: 2
Healthy adult volunteers
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT00755898


Locations
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0W3
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
BioMark Technologies Inc.
Investigators
Principal Investigator: Daniel S Sitar, PhD University of Manitoba
  More Information

Publications:
Responsible Party: Daniel S. Sitar, PhD, University of Manitoba
ClinicalTrials.gov Identifier: NCT00755898     History of Changes
Other Study ID Numbers: B2003:089
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: September 19, 2008
Last Verified: September 2008

Keywords provided by University of Manitoba:
cancer
diagnostic test
urine
amantadine acetylation

Additional relevant MeSH terms:
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents