Acetylamantadine Excretion by Cancer Patients

Cancer Clinical Trial

Official title:

Urinary Excretion of Acetylamantadine by Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277938
• Other study ID #: B2012:063
• Status: Recruiting
• Start date: August 2013
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: University of Manitoba
• Contact: Paramjit S Tappia, PhD
• Phone: 204-258-1230
• Email: ptappia[@]sbrc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	BioMark Technologies Inc., St. Boniface Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetylated Amantadine levels in urine	Change in acetylamantadine excretion	2 and 4 hours after Amantadine ingestion