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Acetylamantadine Excretion by Cancer Patients

Sponsor
University of Manitoba (Other)
Overall Status
Recruiting
CT.gov ID
NCT02277938
Collaborator
BioMark Technologies Inc. (Industry), St. Boniface Hospital (Other)
120
Enrollment
1
Location
100
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Several factors discourage the implementation of cancer screening to the population in general, which would result in earlier diagnosis and an expected improved survival. Concurrent in vivo and in vitro research has shown that drug acetylation activity is increased in cancer. Amantadine may be of value in detecting the presence of cancer. Accordingly, this study will examine how Amantadine is eliminated by the body in cancer patients. This is an important step in validating a cancer detection method that can be implemented economically for screening of large numbers of people.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The study will involve the screening of volunteer patients with various types of cancer to provide a first indication of which types of cancer and at what stage of tumor burden acetylamantadine will be found in patients' plasma, saliva and urine samples. Volunteers will provide complete first morning urine collection prior to amantadine ingestion. The volunteers will then ingest a therapeutic dose of amantadine (200 mg: 2x100mg capsules), at least 2 hours before breakfast (nothing to eat or drink except water after midnight before the scheduled appointment), and their complete urine will be collected at 2 and 4 hours (plus or minus 1 hour) after amantadine ingestion. In addition, blood samples will be taken by venipuncture before and at 2 and 4 hours after drug ingestion. The patients will be asked to provide a saliva sample at the same time as the urine samples are taken after drug ingestion.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Urinary Excretion of Acetylamantadine by Cancer Patients
Actual Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Amantadine

Lung cancer patients being prescribed chemotherapy

Drug: Amantadine
Amantadine is a drug that has been on the market for several years and is currently approved for the treatment of Parkinson's disease and for prevention against influenza A infection. Amantadine may be of value in detecting the presence of cancer.
Other Names:
  • Systemic chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acetylated Amantadine levels in urine [2 and 4 hours after Amantadine ingestion]

      Change in acetylamantadine excretion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: newly diagnosed or untreated cancer (GI, lung, prostate and breast cancer)

    -

    Exclusion Criteria: Any previous adverse reaction to Amantadine

    • currently pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Boniface Hospital Winnipeg Manitoba Canada R2H 2A6

    Sponsors and Collaborators

    • University of Manitoba
    • BioMark Technologies Inc.
    • St. Boniface Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT02277938
    Other Study ID Numbers:
    • B2012:063
    First Posted:
    Oct 29, 2014
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Amantadine

    Study Results

    No Results Posted as of Mar 17, 2021