Urinary Excretion of Acetylamantadine by Cancer Patients

Cancer Clinical Trial

Official title:

Urinary Excretion of Acetylamantadine by Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755898
• Other study ID #: B2003:089
• Status: Completed
• Phase: Phase 2
• Start date: December 2003
• Est. completion date: July 2008

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	BioMark Technologies Inc., Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. doi: 10.1139/cjpp-76-7-8-701. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 hours