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Titolo:
Phase I chemoprevention study of difluoromethylornithine in subjects with organ transplants
Autore:
Carbone, PP; Pirsch, JD; Thomas, JP; Douglas, JA; Verma, AK; Larson, PO; Snow, S; Tutsch, KD; Pauk, D;
Indirizzi:
Univ Wisconsin, Sch Med, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 onsin, Sch Med, Madison, WI 53792 USA Univ Wisconsin, Sch Med, Dept Surg, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 Med, Dept Surg, Madison, WI 53792 USA Univ Wisconsin, Sch Med, Dept Biostat & Informat, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 tat & Informat, Madison, WI 53792 USA Univ Wisconsin, Sch Med, Dept Human Oncol, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 pt Human Oncol, Madison, WI 53792 USA Univ Wisconsin, Sch Med, Dept Med, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 Med, Dept Med, Madison, WI 53792 USA Univ Wisconsin, Sch Med, Ctr Comprehens Canc, Madison, WI 53792 USA Univ Wisconsin Madison WI USA 53792 omprehens Canc, Madison, WI 53792 USA
Titolo Testata:
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION
fascicolo: 6, volume: 10, anno: 2001,
pagine: 657 - 661
SICI:
1055-9965(200106)10:6<657:PICSOD>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
ORNITHINE DECARBOXYLASE ACTIVITY; SKIN-CANCER; ALPHA-DIFLUOROMETHYLORNITHINE; RECIPIENTS; INHIBITION; RETINOIDS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
26
Recensione:
Indirizzi per estratti:
Indirizzo: Carbone, PP K6546 Clin Sci Ctr, Med Oncol Sect, 600 Highland Ave, Madison,WI 53792 USA K6546 Clin Sci Ctr 600 Highland Ave Madison WI USA 53792 2 USA
Citazione:
P.P. Carbone et al., "Phase I chemoprevention study of difluoromethylornithine in subjects with organ transplants", CANC EPID B, 10(6), 2001, pp. 657-661

Abstract

Individuals who receive life saving organ transplants and the required immunosuppression often develop secondary cancers. One of the most common secondary cancers is nonmelanoma skin cancer in sun-exposed areas. Attempts to prevent these cancers have not been successful. Difluoromethylornithine (DFMO), a suicide inhibitor of ornithine decarboxylase (ODC), is a known experimental cancer prevention agent that is being evaluated in a number of human cancer prevention trials. This report describes a Phase I trial in 18 organ transplant recipients, randomized to 1.0 and 0.5 g of DFMO or a placebo,designed to look at short-term toxicities over 28 days as well as the impact of DFMO on two biological parameters, skin polyamines and 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ODC activity. Blood levels of DFMO were also measured. The results indicate that DFMO was well tolerated over the28-day period. The TPA-induced ODC activity in 3-mm skin biopsies was significantly lowered by 80 and 67% at the two dose levels. Polyamine levels were not affected significantly except for putrescine at the 0.5-g level. Blood levels of DFMO were about two times higher than expected, based on our prior pharmacokinetic studies. Our studies indicate that DFMO is a reasonable agent that should be tested further in larger Phase 2b trials in this population as a chemopreventive agent. TPA-induced ODC activity appears to be a relevant intermediate biological assay.

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Documento generato il 10/04/20 alle ore 01:28:30