Urinary Excretion of Acetylamantadine by Cancer Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 18, 2008

Last Updated Date

September 18, 2008

Start Date ^ICMJE

December 2003

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Urinary Excretion of Acetylamantadine by Cancer Patients

Official Title ^ICMJE

Urinary Excretion of Acetylamantadine by Cancer Patients

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

Study Arms / Comparison Groups

Active Comparator: Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
Active Comparator: Healthy adult volunteers

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

July 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00755898

Responsible Party

Daniel S. Sitar, PhD, University of Manitoba

Study ID Numbers ^ICMJE

B2003:089

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Daniel S Sitar, PhD

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

September 2008

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