Urinary Excretion of Acetylamantadine by Cancer Patients
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT00755898
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- Allergy to amantadine hydrochloride
- Chronic liver or kidney disease
- Chronic disease state not controlled by drug therapy, e.g. hypertension
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ingestion of a 200 mg dose of amantadine hydrochloride Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status 2 Ingestion of a 200 mg dose of amantadine hydrochloride Healthy adult volunteers
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada