Urinary Excretion of Acetylamantadine by Cancer Patients - Full Text View

Sponsor:	University of Manitoba
Collaborators:	Canadian Institutes of Health Research (CIHR) BioMark Technologies Inc.
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00755898

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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Urinary Excretion of Acetylamantadine by Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Urine and Urination

Drug Information available for: Amantadine sulfate Amantadine hydrochloride Amantadine

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Bras AP, Jänne J, Porter CW, Sitar DS. Spermidine/spermine n(1)-acetyltransferase catalyzes amantadine acetylation. Drug Metab Dispos. 2001 May;29(5):676-80.

Bras AP, Hoff HR, Aoki FY, Sitar DS. Amantadine acetylation may be effected by acetyltransferases other than NAT1 or NAT2. Can J Physiol Pharmacol. 1998 Jul-Aug;76(7-8):701-6.

Responsible Party:	Daniel S. Sitar, PhD, University of Manitoba
ClinicalTrials.gov Identifier:	NCT00755898 History of Changes
Other Study ID Numbers:	B2003:089
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

cancer
diagnostic test
urine
amantadine acetylation

Additional relevant MeSH terms:

Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on February 12, 2012