Urinary Excretion of Acetylamantadine by Cancer Patients

University of Manitoba

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00755898

B2003:089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

2

Active Comparator group

Description:

Healthy adult volunteers

Treatment:

Drug: Ingestion of a 200 mg dose of amantadine hydrochloride

Drug: Ingestion of a 200 mg dose of amantadine hydrochloride