Acetylamantadine Excretion by Cancer Patients

NCT ID: NCT02277938

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amantadine

Lung cancer patients being prescribed chemotherapy

Amantadine

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Systemic chemotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

* currently pregnant or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioMark Technologies Inc.

INDUSTRY

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paramjit S Tappia, PhD

Role: CONTACT

204-258-1230

Andrew Maksymiuk, MD

Role: CONTACT

204-787-1884

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paramjit S Tappia, PhD

Role: primary

204-258-1230

Andrew Maksymiuk, MD

Role: backup

204-7871884

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 11814066 (View on PubMed)

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.

Reference Type RESULT
PMID: 11814067 (View on PubMed)

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.

Reference Type RESULT
PMID: 10030449 (View on PubMed)

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.

Reference Type RESULT
PMID: 11302933 (View on PubMed)

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.

Reference Type RESULT
PMID: 7007382 (View on PubMed)

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.

Reference Type RESULT
PMID: 7141002 (View on PubMed)

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

Reference Type RESULT
PMID: 3322538 (View on PubMed)

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.

Reference Type RESULT
PMID: 10646846 (View on PubMed)

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.

Reference Type RESULT
PMID: 5286749 (View on PubMed)

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.

Reference Type RESULT
PMID: 9061454 (View on PubMed)

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.

Reference Type RESULT
PMID: 6692383 (View on PubMed)

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.

Reference Type RESULT
PMID: 4065178 (View on PubMed)

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.

Reference Type RESULT
PMID: 2493102 (View on PubMed)

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.

Reference Type RESULT
PMID: 1998945 (View on PubMed)

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.

Reference Type RESULT
PMID: 1026855 (View on PubMed)

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.

Reference Type RESULT
PMID: 704038 (View on PubMed)

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

Reference Type RESULT
PMID: 692806 (View on PubMed)

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

Reference Type RESULT
PMID: 11478689 (View on PubMed)

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.

Reference Type RESULT
PMID: 9572394 (View on PubMed)

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.

Reference Type RESULT
PMID: 709306 (View on PubMed)

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.

Reference Type RESULT
PMID: 7059417 (View on PubMed)

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

Reference Type RESULT
PMID: 14211150 (View on PubMed)

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.

Reference Type RESULT
PMID: 903875 (View on PubMed)

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.

Reference Type RESULT
PMID: 1581359 (View on PubMed)

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.

Reference Type RESULT
PMID: 8427870 (View on PubMed)

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

Reference Type RESULT
PMID: 3280212 (View on PubMed)

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.

Reference Type RESULT
PMID: 8330461 (View on PubMed)

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.

Reference Type RESULT
PMID: 1629283 (View on PubMed)

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.

Reference Type RESULT
PMID: 10580511 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2012:063

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Symptom Burden in Head and Neck Cancer
NCT01219673 TERMINATED PHASE1/PHASE2
Evaluation of Side Effects of Mitotane
NCT00568139 ACTIVE_NOT_RECRUITING