A phase I trial of perillyl alcohol administered four times daily for 14 days out of 28 days

Cancer Chemotherapy and Pharmacology

Volumn 54, Issue 4, 2004, Pages 368-376

  Bailey, Howard H ^a   Wilding, George ^a   Tutsch, Kendra D ^a   Arzoomanian, Rhoda Z ^a   Alberti, Dona ^a   Feierabend, Chris ^a   Simon, Kris ^a   Marnocha, Rebecca ^a   Holstein, Sarah A ^b   Stewart, Jan ^b   Lewis, Kriste A ^b   Hohl, Raymond J ^b  

^a UNIVERSITY OF WISCONSIN   (United States)

^b UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

Author keywords

Monoterpene; Perillyl alcohol; Phase I

Indexed keywords

DIHYDROPERILLIC ACID; PERILLIC ACID; PERILLYL ALCOHOL; RAS PROTEIN; TRANSFORMING GROWTH FACTOR BETA; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ACUTE PANCREATITIS; ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; CHEMOPROPHYLAXIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DIET RESTRICTION; DOSE RESPONSE; DRUG ACTIVITY; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG MECHANISM; ERUCTATION; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPOKALEMIA; MALE; NAUSEA; NONHODGKIN LYMPHOMA; PERIPHERAL LYMPHOCYTE; PRIORITY JOURNAL;

ADULT; AGED; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ENZYME INHIBITORS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MONOTERPENES; NEOPLASMS;

EID: 3242742790     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-004-0788-z     Document Type: Article

References (24)

1. Ariazi EA, Satomi Y, Ellis MJ, Haag JD, Shi W, Sattler CA, Gould MN (1999) Activation of the transforming growth factor β (beta) signaling pathway and induction of cytostasis and apoptosis in mammary carcinomas treated with the anticancer agent perillyl alcohol. Cancer Res 59:1917
2. Burke YD, Stark MJ, Roach SL, Sen SE, Crowell PL (1997) Inhibition of pancreatic cancer growth by the isoprenoids farnesyl and geraniol. Lipids 32:151
3. Crowell PL, Chang RR, Ren ZB, Elson CE, Gould MN (1991) Selective inhibition of isoprenylation of 21-26-kDa proteins by the anticarcinogen D-limonene and its metabolites. J Biol Chem 266:17679
4. Crowell PL, Ren Z, Lin S, Vedejs E, Gould M (1994) Structure-activity relationships among monoterpene inhibitors of protein isoprenylation and cell proliferation. Biochem Pharmacol 47:1404
5. Elegbede A, Elson CE, Tanner MA, Qureshi A, Gould MN (1986) Regression of rat mammary tumors following dietary D-limonene. J Natl Cancer Inst 76:323
6. Gibaldi M, Perrier D (1982) Pharmacokinetics, 2nd edn. Marcel Dekker, New York
7. Haag JD, Gould MN (1994) Mammary carcinoma regression induced by perillyl alcohol, a hydroxylated analog of limonene. Cancer Chemother Pharmacol 34:477
8. Haag JD, Lindstrom MJ, Gould MN (1992) Limonene-induced regression of mammary carcinomas. Cancer Res 52:4021
9. Hardcastle IR, Rowlands MG, Barber AM, Grimshaw RM, Mohan MK, Nutley BP, Jarman M (1999) Inhibition of protein prenylation by metabolites of limonene. Biochem Pharmacol 57:801
10. Hohl RJ, Lewis K (1995) Differential effects of monoterpenes and lovastatin on RAS processing. J Biol Chem 270:17508
11. Holstein SA, Hohl RJ (2003) Monoterpene regulation of Ras and Ras-related protein expression. J Lipid Res 44:1209
12. Hudes GR, Szarka CE, Adams A, Ranganathan S, McCauley RA, Weiner LM, Halberr T, Qian M, Gallo JM (2000) Phase I pharmacokinetic trial of perillyl alcohol (NSC 641066) in patients with refractory solid malignancies. Clin Cancer Res 6:3071
13. Jirtle RL, Haag JD, Ariazi EA, Gould MN (1993) Increased levels of mannose 6-phosphate/insulin-like growth factor II (M6P/IGF-II) receptor and transforming growth factor beta 1 (TGF-β1) levels during monoterpene-induced regression of mammary tumors. Cancer Res 53:3849
14. Kanai T, Hirohashi S, Noguchi M, Shimoyama Y, Shimosato Y, Noguchi S, Nishimura S, Abe O (1987) Monoclonal antibody highly sensitive for the detection of ras p21 in immunoblotting analysis. Jpn J Cancer Res 78:1314
15. Lluria-Prevatt M, Morreale J, Gregus J, Alberts DS, Kaper F, Giaccia A, Broome Powell M (2002) Effects of perillyl alcohol on melanoma in the TPras mouse model. Cancer Epidemiol Biomarkers Prev 11:573
16. Lowry OH, Rosenbrough NJ, Farr AL, Randall RJ (1951) Protein measurement with the Folin phenol reagent. J Biol Chem 193:265
17. Murren JR, Pizzorno G, DiStasio SA, McKeon A, Peccerillo K, Gollerkari A, McMurray W, Burtness BA, Rutherford T, Li X, Ho PT, Sartorelli A (2002) Phase I study of perillyl alcohol in patients with refractory malignancies. Cancer Biol Ther 1:130
18. Phillips LR, Malspeis L, Supko JG (1995) Pharmacokinetics of active drug metabolites after oral administration of perillyl alcohol, an investigational antineoplastic agent, to the dog. Drug Metab Dispos 23:676
19. Reddy BS, Wang CX, Samaha H, Lubet R, Steele VE, Kelloff GJ, Rao CV (1997) Chemoprevention of colon carcinogenesis by dietary perillyl alcohol. Cancer Res 57:420
20. Ripple GH, Gould MN, Stewart JA, Tutsch KD, Arzoomanian RZ, Alberti D, Feierabend C, Pomplun M, Wilding G, Bailey HH (1998) Phase I clinical trial of perillyl alcohol administered daily. Clin Cancer Res 4:1159
21. Ripple GH, Gould MN, Arzoomanian RZ, Alberti D, Feierabend C, Simon K, Binger K, Tutsch KD, Pomplun M, Wahamaki A, Marnocha R, Wilding G, Bailey HH (2000) Phase I clinical and pharmacokinetic study of perillyl alcohol administered four times a day. Clin Cancer Res 6:390
22. Shi W, Gould MN (2002) Induction of cytostasis in mammary carcinoma cells treated with the anticancer agent perillyl alcohol. Carcinogenesis 23:131
23. Vigushin DM, Poon G, Boddy A, Jarman M, Coombes RC (1998) Phase I and pharmacokinetic study of D-limonene in patients with advanced cancer. Cancer Chemother Pharmacol 42:111
24. Wattenberg LW, Sparnins VL, Coccia JB (1989) Inhibition of TV-nitrosodiethylamine carcinogenesis in mice by naturally occurring organosulfur compounds and monoterpenes. Cancer Res 49:2689