Urinary Excretion of Acetylamantadine by Cancer Patients

NCT ID: NCT00755898

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2008-07-31

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.

Conditions

Cancer

Keywords

cancer; diagnostic test; urine; amantadine acetylation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status

Group Type: ACTIVE_COMPARATOR

Ingestion of a 200 mg dose of amantadine hydrochloride

Intervention Type: DRUG

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

2

Healthy adult volunteers

Group Type: ACTIVE_COMPARATOR

Ingestion of a 200 mg dose of amantadine hydrochloride

Intervention Type: DRUG

Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

BioMark Technologies Inc.

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

DanielSitar

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S Sitar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 11302933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10030449 (View on PubMed)

Other Identifiers

B2003:089

Identifier Type: -

Identifier Source: org_study_id