NCT02277938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

8.3 years

First QC Date

October 27, 2014

Last Update Submit

March 15, 2021

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Acetylated Amantadine levels in urine

    Change in acetylamantadine excretion

    2 and 4 hours after Amantadine ingestion

Study Arms (1)

Amantadine

Lung cancer patients being prescribed chemotherapy

Drug: Amantadine

Interventions

AmantadineDRUG

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.

Also known as: Systemic chemotherapy
Amantadine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with newly diagnosed cancer

You may not qualify if:

  • currently pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Related Publications (29)

  • 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.

    PMID: 11814066RESULT

  • 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.

    PMID: 11814067RESULT

  • 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.

    PMID: 10030449RESULT

  • 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.

    PMID: 11302933RESULT

  • 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.

    PMID: 7007382RESULT

  • 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.

    PMID: 7141002RESULT

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

    PMID: 3322538RESULT

  • 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. Erratum In: Cancer Res 2000 Mar 1;60(5):1472. Saverio, B [corrected to Bettuzzi, S]; Pierpaola, D [corrected to Davalli, P]; Serenella, A [corrected to Astancolle, S]; ,C [corrected to Carani, C]; Bruno, M [corrected to Madeo, B]; Auro, T [corrected to Tampieri, A]; Arnaldo, C [corrected to Corti, A].

    PMID: 10646846RESULT

  • 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.

    PMID: 5286749RESULT

  • 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.

    PMID: 9061454RESULT

  • 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.

    PMID: 6692383RESULT

  • 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.

    PMID: 4065178RESULT

  • 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.

    PMID: 2493102RESULT

  • 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.

    PMID: 1998945RESULT

  • 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.

    PMID: 1026855RESULT

  • Bulovskaya LN, Krupkin RG, Bochina TA, Shipkova AA, Pavlova MV. Acetylator phenotype in patients with breast cancer. Oncology. 1978;35(4):185-8. doi: 10.1159/000225282.

    PMID: 704038RESULT

  • Chekharina YeA, Bulovskaya LN, Pavlova MV, Krupkin RG. Activity of N-acetyltransferase in patients with malignant lymphomas. Neoplasma. 1978;25(4):471-5.

    PMID: 692806RESULT

  • Geylan YS, Dizbay S, Guray T. Arylamine N-acetyltransferase activities in human breast cancer tissues. Neoplasma. 2001;48(2):108-11.

    PMID: 11478689RESULT

  • Estrada-Rodgers L, Levy GN, Weber WW. Characterization of a hormone response element in the mouse N-acetyltransferase 2 (Nat2*) promoter. Gene Expr. 1998;7(1):13-24.

    PMID: 9572394RESULT

  • Olsen H, Morland J. Ethanol-induced increase in drug acetylation in man and isolated rat liver cells. Br Med J. 1978 Nov 4;2(6147):1260-2. doi: 10.1136/bmj.2.6147.1260.

    PMID: 709306RESULT

  • Olsen H, Morland J. Ethanol-induced increase in procainamide acetylation in man. Br J Clin Pharmacol. 1982 Feb;13(2):203-8. doi: 10.1111/j.1365-2125.1982.tb01357.x.

    PMID: 7059417RESULT

  • LESTER D. THE ACETYLATION OF ISONIAZID IN ALCOHOLICS. Q J Stud Alcohol. 1964 Sep;25:541-3. No abstract available.

    PMID: 14211150RESULT

  • Thomas BH, Solomonraj G. Drug interactions with isoniazid metabolism in rats. J Pharm Sci. 1977 Sep;66(9):1322-6. doi: 10.1002/jps.2600660930.

    PMID: 903875RESULT

  • Obayashi M, Matsui-Yuasa I, Kitano A, Kobayashi K, Otani S. Posttranslational regulation of spermidine/spermine N1-acetyltransferase with stress. Biochim Biophys Acta. 1992 May 7;1131(1):41-6. doi: 10.1016/0167-4781(92)90096-i.

    PMID: 1581359RESULT

  • Perin A, Sessa A. Polyamine acetylation in rat liver following long-term ethanol ingestion. Biochim Biophys Acta. 1993 Feb 13;1156(2):113-6. doi: 10.1016/0304-4165(93)90124-q.

    PMID: 8427870RESULT

  • Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.

    PMID: 3280212RESULT

  • Gaudry SE, Sitar DS, Smyth DD, McKenzie JK, Aoki FY. Gender and age as factors in the inhibition of renal clearance of amantadine by quinine and quinidine. Clin Pharmacol Ther. 1993 Jul;54(1):23-7. doi: 10.1038/clpt.1993.104.

    PMID: 8330461RESULT

  • Hyvonen T, Keinanen TA, Khomutov AR, Khomutov RM, Eloranta TO. Monitoring of the uptake and metabolism of aminooxy analogues of polyamines in cultured cells by high-performance liquid chromatography. J Chromatogr. 1992 Feb 7;574(1):17-21. doi: 10.1016/0378-4347(92)80093-6.

    PMID: 1629283RESULT

  • Lou G, Zhang M, Minuk GY. Effects of acute ethanol exposure on polyamine and gamma-aminobutyric acid metabolism in the regenerating liver. Alcohol. 1999 Nov;19(3):219-27. doi: 10.1016/s0741-8329(99)00050-6.

    PMID: 10580511RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva, blood, urine

MeSH Terms

Conditions

Neoplasms

Interventions

AmantadineNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCombined Modality TherapyTherapeutics

Central Study Contacts

Paramjit S Tappia, PhD

CONTACT

204-258-1230ptappia@sbrc.ca

Andrew Maksymiuk, MD

CONTACT

204-787-1884amaksymiuk@cancercare.mb.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

CA(1)