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eflornithine and Local Neoplasm Recurrence

eflornithine has been researched along with Local Neoplasm Recurrence in 18 studies

Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.

Research Excerpts

ExcerptRelevanceReference
"This study compared the antitumor activity of oral eflornithine with that of oral eflornithine combined with intravenous mitoguazone in the treatment of patients with recurrent or progressive glioblastoma multiforme as well as nonglioblastoma anaplastic gliomas."9.07Treatment of recurrent gliomas with eflornithine. ( Gleason, MJ; Ictech, S; Levin, VA; Malec, M; Prados, MD; Yung, WK, 1992)
"The polyamine-inhibitory regimen difluoromethylornithine (DFMO)+sulindac has marked efficacy in preventing metachronous colorectal adenomas."7.79Role of dietary polyamines in a phase III clinical trial of difluoromethylornithine (DFMO) and sulindac for prevention of sporadic colorectal adenomas. ( Gerner, EW; McLaren, CE; Meyskens, FL; Raj, KP; Rock, CL; Zell, JA; Zoumas-Morse, C, 2013)
"A phase III clinical trial assessed the recurrence of adenomatous polyps after treatment for 36 months with difluoromethylornithine (DFMO) plus sulindac or matched placebos."5.13Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas. ( Chen, WP; Fujikawa-Brooks, S; Gerner, EW; Gillen, DL; McLaren, CE; Meyskens, FL; Pelot, D, 2008)
"This study compared the antitumor activity of oral eflornithine with that of oral eflornithine combined with intravenous mitoguazone in the treatment of patients with recurrent or progressive glioblastoma multiforme as well as nonglioblastoma anaplastic gliomas."5.07Treatment of recurrent gliomas with eflornithine. ( Gleason, MJ; Ictech, S; Levin, VA; Malec, M; Prados, MD; Yung, WK, 1992)
"The polyamine-inhibitory regimen difluoromethylornithine (DFMO)+sulindac has marked efficacy in preventing metachronous colorectal adenomas."3.79Role of dietary polyamines in a phase III clinical trial of difluoromethylornithine (DFMO) and sulindac for prevention of sporadic colorectal adenomas. ( Gerner, EW; McLaren, CE; Meyskens, FL; Raj, KP; Rock, CL; Zell, JA; Zoumas-Morse, C, 2013)
" Experiments were carried out on the trastuzumab-resistant human epidermal growth factor receptor 2-overexpressing breast cancer cell line JIMT-1 to unravel the chemotherapeutic effects of the polyamine analogue [1N,12N]bis(ethyl)-cis-6,7-dehydrospermine (PG11047) and of the polyamine biosynthetic inhibitor 2-difluoromethylornithine (DFMO) on the CD44+CD24- CSC population."3.76Reduction of the putative CD44+CD24- breast cancer stem cell population by targeting the polyamine metabolic pathway with PG11047. ( Cirenajwis, H; Hegardt, C; Honeth, G; Marton, LJ; Oredsson, SM; Smiljanic, S, 2010)
"Two patients died of bladder cancer at 2 and 4 years after randomization, both in the difluoromethylornithine arm."2.72Randomized prospective phase III trial of difluoromethylornithine vs placebo in preventing recurrence of completely resected low risk superficial bladder cancer. ( Kim, D; Kim, KM; Messing, E; Parnes, H; Saltzstein, D; Schultz, M; Sharkey, F; Wilding, G, 2006)
"Patients with resected superficial bladder cancers were studied."2.68Toxicity evaluation of difluoromethylornithine: doses for chemoprevention trials. ( Loprinzi, CL; Love, RR; Messing, EM; Morton, RF; Novotny, P; O'Fallon, JR; Poon, MA; Quella, SK; Trump, DL, 1996)

Research

Studies (18)

TimeframeStudies, this research(%)All Research%
pre-19903 (16.67)18.7374
1990's5 (27.78)18.2507
2000's5 (27.78)29.6817
2010's4 (22.22)24.3611
2020's1 (5.56)2.80

Authors

AuthorsStudies
Batth, IS1
Dao, L1
Satelli, A1
Mitra, A1
Yi, S1
Noh, H1
Li, H1
Brownlee, Z1
Zhou, S1
Bond, J1
Wang, J1
Gill, J1
Sholler, GS1
Li, S1
Sporn, MB1
Hong, WK1
McLaren, CE2
Fujikawa-Brooks, S1
Chen, WP1
Gillen, DL1
Pelot, D1
Gerner, EW4
Meyskens, FL2
Cirenajwis, H1
Smiljanic, S1
Honeth, G1
Hegardt, C1
Marton, LJ1
Oredsson, SM1
Laukaitis, CM1
Rial, NS1
Zell, JA2
Cohen, AM1
Raj, KP1
Rock, CL1
Zoumas-Morse, C1
Manni, A1
Washington, S1
Craig, L1
Cloud, M1
Griffith, JW1
Verderame, MF1
Texter, LJ1
Mauger, D1
Demers, LM1
Harms, JF1
Welch, DR1
Messing, E1
Kim, KM1
Sharkey, F1
Schultz, M1
Parnes, H1
Kim, D1
Saltzstein, D1
Wilding, G1
Tuma, R1
Loprinzi, CL2
Messing, EM2
O'Fallon, JR2
Poon, MA1
Love, RR1
Quella, SK1
Trump, DL1
Morton, RF1
Novotny, P1
Buckner, JC1
Burch, PA1
Cascino, TL1
Scheithauer, BW1
Hess, KR1
Wong, ET1
Jaeckle, KA1
Kyritsis, AP1
Levin, VA4
Prados, MD3
Yung, WK2
Gleason, MJ1
Ictech, S1
Malec, M1
Prados, M1
Rodriguez, L1
Chamberlain, M1
Silver, P2
Levin, V1
Chamberlain, MC1
Choucair, AK1
Berger, MS1
Seager, M1
Gutin, PH1
Davis, RL1
Wilson, CB1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission[NCT02395666]Phase 2140 participants (Actual)Interventional2015-03-05Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC)

"Pharmacokinetic assay AUC(0-6 hr)/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days" (NCT02395666)
Timeframe: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days

Interventionhr*ng/mL (Mean)
Study Subjects Consented to PK Collection47024

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

To continue to determine the safety and tolerability of DFMO as a single agent and in pediatric and young adult patients with high risk neuroblastoma that is in remission. (NCT02395666)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
DFMO Twice Daily57

Number of Participants With Event Free Survival (EFS) During Study.

To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS) (NCT02395666)
Timeframe: 2 Years

Interventionpercentage of subjects without an event (Mean)
Stratum 184
Stratum 251

Peak Plasma Concentration (Cmax)

"Pharmacokinetic assay Cmax/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days." (NCT02395666)
Timeframe: Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days

Interventionng/mL (Mean)
Study Subjects Consented to PK Collection11958

Percentage of Participants With Overall Survival (OS)

To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS) (NCT02395666)
Timeframe: 2 Years

Interventionpercentage of subjects without an event (Mean)
Stratum 197
Stratum 284

Test the Association of Survival With ODC1 Genotype

"Tests (p-value) of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.~Blood: microRNA analysis as predictor of DFMO effect, ornithine decarboxylase (ODC) single nucleotide polymorphism (SNP) analysis in DNA isolated from nucleated cells" (NCT02395666)
Timeframe: 2 years

Interventionp-value (Number)
GG, GT, TT0.96
GG or GT, TT0.58
GG, GT or TT0.67

Time to Reach Peak Plasma Concentration (Tmax)

"Pharmacokinetic assay- tmax, hr~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days" (NCT02395666)
Timeframe: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days

Interventionhours (Mean)
Study Subjects Consented to PK Collection3.3

Reviews

4 reviews available for eflornithine and Local Neoplasm Recurrence

ArticleYear
DFMO: targeted risk reduction therapy for colorectal neoplasia.
    Best practice & research. Clinical gastroenterology, 2011, Volume: 25, Issue:4-5

    Topics: Adenoma; Animals; Anticarcinogenic Agents; Chemoprevention; Colorectal Neoplasms; Eflornithine; Enzy

2011
Clinical end points for developing pharmaceuticals to manage patients with a sporadic or genetic risk of colorectal cancer.
    Expert review of gastroenterology & hepatology, 2012, Volume: 6, Issue:4

    Topics: Adenomatous Polyposis Coli; Antineoplastic Agents; Chemoprevention; Clinical Trials as Topic; Colono

2012
A prospective clinical trial of difluoromethylornithine (DFMO) in patients with resected superficial bladder cancer.
    Journal of cellular biochemistry. Supplement, 1992, Volume: 16I

    Topics: Clinical Trials as Topic; Eflornithine; Humans; Neoplasm Invasiveness; Neoplasm Recurrence, Local; N

1992
Chemotherapy of primary brain tumors.
    Neurologic clinics, 1985, Volume: 3, Issue:4

    Topics: Antineoplastic Combined Chemotherapy Protocols; Astrocytoma; Brain Neoplasms; Brain Stem; Child; Efl

1985

Trials

6 trials available for eflornithine and Local Neoplasm Recurrence

ArticleYear
Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas.
    Cancer prevention research (Philadelphia, Pa.), 2008, Volume: 1, Issue:7

    Topics: Adenomatous Polyps; Antineoplastic Combined Chemotherapy Protocols; Audiometry, Pure-Tone; Colonic N

2008
Randomized prospective phase III trial of difluoromethylornithine vs placebo in preventing recurrence of completely resected low risk superficial bladder cancer.
    The Journal of urology, 2006, Volume: 176, Issue:2

    Topics: Aged; Antineoplastic Agents; Carcinoma, Transitional Cell; Double-Blind Method; Eflornithine; Female

2006
Toxicity evaluation of difluoromethylornithine: doses for chemoprevention trials.
    Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 1996, Volume: 5, Issue:5

    Topics: Antineoplastic Agents; Carcinoma, Transitional Cell; Chemoprevention; Dose-Response Relationship, Dr

1996
Phase II trial of recombinant interferon-alpha-2a and eflornithine in patients with recurrent glioma.
    Journal of neuro-oncology, 1998, Volume: 36, Issue:1

    Topics: Adult; Aged; Disease Progression; Drug Therapy, Combination; Eflornithine; Female; Glioma; Humans; I

1998
Response and progression in recurrent malignant glioma.
    Neuro-oncology, 1999, Volume: 1, Issue:4

    Topics: Actuarial Analysis; Adolescent; Adult; Aged; Aged, 80 and over; Alitretinoin; Antineoplastic Combine

1999
Treatment of recurrent gliomas with eflornithine.
    Journal of the National Cancer Institute, 1992, Sep-16, Volume: 84, Issue:18

    Topics: Adolescent; Adult; Aged; Brain Neoplasms; Child; Child, Preschool; Eflornithine; Female; Glioblastom

1992

Other Studies

8 other studies available for eflornithine and Local Neoplasm Recurrence

ArticleYear
Cell surface vimentin-positive circulating tumor cell-based relapse prediction in a long-term longitudinal study of postremission neuroblastoma patients.
    International journal of cancer, 2020, 12-15, Volume: 147, Issue:12

    Topics: Biomarkers, Tumor; Cell Line, Tumor; Clinical Trials, Phase II as Topic; Early Detection of Cancer;

2020
Clinical prevention of recurrence of colorectal adenomas by the combination of difluoromethylornithine and sulindac: an important milestone.
    Cancer prevention research (Philadelphia, Pa.), 2008, Volume: 1, Issue:1

    Topics: Adenoma; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Colorectal Neopla

2008
Reduction of the putative CD44+CD24- breast cancer stem cell population by targeting the polyamine metabolic pathway with PG11047.
    Anti-cancer drugs, 2010, Volume: 21, Issue:10

    Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Breast Neoplasms;

2010
Role of dietary polyamines in a phase III clinical trial of difluoromethylornithine (DFMO) and sulindac for prevention of sporadic colorectal adenomas.
    British journal of cancer, 2013, Feb-19, Volume: 108, Issue:3

    Topics: Adenoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Tr

2013
Effects of alpha-difluoromethylornithine on local recurrence and pulmonary metastasis from MDA-MB-435 breast cancer xenografts in nude mice.
    Clinical & experimental metastasis, 2003, Volume: 20, Issue:4

    Topics: Animals; Eflornithine; Enzyme Inhibitors; Female; Green Fluorescent Proteins; Humans; Luminescent Pr

2003
Drugs to prevent colon cancer show promise, but hurdles remain for chemoprevention.
    Journal of the National Cancer Institute, 2008, Jun-04, Volume: 100, Issue:11

    Topics: Adenoma; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Combined Chemotherapy Prot

2008
Treatment of recurrent gliomas with 1,3-bis(2-chloroethyl)-1-nitrosourea and alpha-difluoromethylornithine.
    Neurosurgery, 1989, Volume: 24, Issue:6

    Topics: Antineoplastic Combined Chemotherapy Protocols; Astrocytoma; Brain Neoplasms; Carmustine; Combined M

1989
Phase I-II study of eflornithine and mitoguazone combined in the treatment of recurrent primary brain tumors.
    Cancer treatment reports, 1987, Volume: 71, Issue:5

    Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Child; Drug Eval

1987