Urinary Excretion of Acetylamantadine by Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urinary Excretion of Acetylamantadine by Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
* Drug: Ingestion of a 200 mg dose of amantadine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.<br>|
| Active Comparator: 2<br>Healthy adult volunteers | Drug: Ingestion of a 200 mg dose of amantadine hydrochloride<br>* Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, diagnostic test, urine, amantadine acetylation