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CancerNCT02277938

Acetylamantadine Excretion by Cancer Patients

An observational study of Cancer, run by University of Manitoba at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer
What is being tested?
Amantadine
How many people
120 participants
Where
1 siteCanada
Study dates
Aug 2013to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with newly diagnosed cancer

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

Trial locations and contacts

1 site in 1 country.

Paramjit S Tappia, PhD contact

204-258-1230

ptappia@sbrc.ca

Andrew Maksymiuk, MD contact

204-787-1884

amaksymiuk@cancercare.mb.ca

Canada1 site, 1 recruiting

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

    Paramjit S Tappia, PhD, 204-258-1230, ptappia@sbrc.ca

    Andrew Maksymiuk, MD, 204-7871884, amaksymiuk@cancercare.mb.ca

    Recruiting

Other trials in Canada

About this study

Official title: Urinary Excretion of Acetylamantadine by Cancer Patients

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.

Read the 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.

Conditions
Cancer
Being tested
Amantadine
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmantadineDrug

    Also called Systemic chemotherapy

    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.

Study groups in NCT02277938
Study groupRoleWhat they receive
AmantadineLung cancer patients being prescribed chemotherapy
Receives: Drug: Amantadine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acetylated Amantadine levels in urine

    Change in acetylamantadine excretion

    Measured: 2 and 4 hours after Amantadine ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02277938
Sponsor's protocol ID
B2012:063
Status last verified
Mar 2021
First submitted
27 Oct 2014
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • Young RC. Cancer statistics, 2002: progress or cause for concern? CA Cancer J Clin. 2002 Jan-Feb;52(1):6-7. doi: 10.3322/canjclin.52.1.6. No abstract available.

    PubMed 11814066

  • Smith RA, Cokkinides V, von Eschenbach AC, Levin B, Cohen C, Runowicz CD, Sener S, Saslow D, Eyre HJ; American Cancer Society. American Cancer Society guidelines for the early detection of cancer. CA Cancer J Clin. 2002 Jan-Feb;52(1):8-22. doi: 10.3322/canjclin.52.1.8.

    PubMed 11814067

  • Bras AP, Hoff HR, Aoki FY, Sitar DS. Amantadine acetylation may be effected by acetyltransferases other than NAT1 or NAT2. Can J Physiol Pharmacol. 1998 Jul-Aug;76(7-8):701-6. doi: 10.1139/cjpp-76-7-8-701.

    PubMed 10030449

  • Bras AP, Janne J, Porter CW, Sitar DS. Spermidine/spermine n(1)-acetyltransferase catalyzes amantadine acetylation. Drug Metab Dispos. 2001 May;29(5):676-80.

    PubMed 11302933

  • Matsui I, Wiegand L, Pegg AE. Properties of spermidine N-acetyltransferase from livers of rats treated with carbon tetrachloride and its role in the conversion of spermidine into putrescine. J Biol Chem. 1981 Mar 10;256(5):2454-9. No abstract available.

    PubMed 7007382

  • Pegg AE, Seely JE, Poso H, della Ragione F, Zagon IA. Polyamine biosynthesis and interconversion in rodent tissues. Fed Proc. 1982 Dec;41(14):3065-72.

    PubMed 7141002

  • Seiler N. Functions of polyamine acetylation. Can J Physiol Pharmacol. 1987 Oct;65(10):2024-35. doi: 10.1139/y87-317.

    PubMed 3322538

  • Bettuzzi S, Davalli P, Astancolle S, Carani C, Madeo B, Tampieri A, Corti A. Tumor progression is accompanied by significant changes in the levels of expression of polyamine metabolism regulatory genes and clusterin (sulfated glycoprotein 2) in human prostate cancer specimens. Cancer Res. 2000 Jan 1;60(1):28-34.

    PubMed 10646846

  • Russell DH. Increased polyamine concentrations in the urine of human cancer patients. Nat New Biol. 1971 Sep 29;233(39):144-5. doi: 10.1038/newbio233144a0. No abstract available.

    PubMed 5286749

  • Suh JW, Lee SH, Chung BC, Park J. Urinary polyamine evaluation for effective diagnosis of various cancers. J Chromatogr B Biomed Sci Appl. 1997 Jan 24;688(2):179-86. doi: 10.1016/s0378-4347(96)00266-6.

    PubMed 9061454

  • Takenoshita S, Matsuzaki S, Nakano G, Kimura H, Hoshi H, Shoda H, Nakamura T. Selective elevation of the N1-acetylspermidine level in human colorectal adenocarcinomas. Cancer Res. 1984 Feb;44(2):845-7.

    PubMed 6692383

  • Kingsnorth AN, Wallace HM. Elevation of monoacetylated polyamines in human breast cancers. Eur J Cancer Clin Oncol. 1985 Sep;21(9):1057-62. doi: 10.1016/0277-5379(85)90291-3.

    PubMed 4065178

  • Pine MJ, Huben RP, Pegg AE. Production of N1-acetyl spermidine by renal cell tumors. J Urol. 1989 Mar;141(3):651-5. doi: 10.1016/s0022-5347(17)40925-6.

    PubMed 2493102

  • Sessa A, Perin A. Increased synthesis of N1-acetylspermidine in hepatic preneoplastic nodules and hepatomas. Cancer Lett. 1991 Feb;56(2):159-63. doi: 10.1016/0304-3835(91)90091-u.

    PubMed 1998945

  • Dilman VM, Anisimov VN, Kolosov AI, Bulovskaya LN. On the relationship between the activity of acetylation, growth of experimental tumors and efficacy of their suppression by hydrazine sulphate. Oncology. 1976;33(5-6):219-21. doi: 10.1159/000225149.

    PubMed 1026855

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paramjit S Tappia, PhD (204-258-1230, ptappia@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acetylated Amantadine levels in urine (time frame: 2 and 4 hours after Amantadine ingestion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02277938, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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