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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ingestion of a 200 mg dose of amantadine hydrochloride

Drug

Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

BioMark Technologies Inc.
Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: Sep 19, 2008
Registry last updated: Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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