A phase 2a study of topical perillyl alcohol cream for chemoprevention of skin cancer

Cancer Prevention Research

Volumn 3, Issue 2, 2010, Pages 160-169

  Stratton, Steven P ^a,c   Alberts, David S ^a,c   Einspahr, Janine G ^a,c   Sagerman, Paul M ^b,c   Warneke, James A ^a,c   Curiel Lewandrowski, Clara ^a,c   Myrdal, Paul B ^b,c   Karlage, Kelly L ^b   Nickoloff, Brian J ^d   Brooks, Chris ^c   Saboda, Kathylynn ^c   Yozwiak, Michael L ^c   Krutzsch, Mary F ^c   Hu, Chengcheng ^b,c   Lluria Prevatt, Maria ^c   Dong, Zigang ^e   Timothy Bowden, G ^a,c   Bartels, Peter H ^c  

^a UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

^c UNIVERSITY OF ARIZONA   (United States)

^d LOYOLA UNIVERSITY HEALTH SYSTEM   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PERILLYL ALCOHOL; PLACEBO; PROTEIN P53;

ACTINIC KERATOSIS; ADULT; AGED; ARTICLE; CANCER PREVENTION; CELL PROLIFERATION; CHROMATIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREAM; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; EPIDERMIS; ERYTHEMA; FEMALE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERPIGMENTATION; IMMUNOHISTOCHEMISTRY; KARYOMETRY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; PHOTODERMATOSIS; PRIORITY JOURNAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; SKIN BIOPSY; SKIN CANCER; SKIN DEFECT; SKIN REDNESS; SUN EXPOSURE; TREATMENT RESPONSE; WRINKLE;

ADMINISTRATION, TOPICAL; AGED; ANTINEOPLASTIC AGENTS; APOPTOSIS; CHEMOPREVENTION; CHROMATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; KARYOTYPING; MALE; MIDDLE AGED; MONOTERPENES; SKIN NEOPLASMS;

EID: 77949766282     PISSN: 19406207     EISSN: None     Source Type: Journal    
DOI: 10.1158/1940-6207.CAPR-09-0183     Document Type: Article

References (25)

1. Mills JJ, Chari RS, Boyer IJ, Gould MN, Jirtle RL. Induction of apoptosis in liver tumors by the monoterpene perillyl alcohol. Cancer Res 1995;55:979-83.
2. Barthelman M, Chen W, Gensler HL, Huang C, Dong Z, Bowden GT. Inhibitory effects of perillyl alcohol on UVB-induced murine skin cancer and AP-1 transactivation. Cancer Res 1998;58:711-6.
3. Cooper SJ, MacGowan J, Ranger-Moore J, Young MR, Colburn NH, Bowden GT, et al. Expression of dominant negative c-jun inhibits ultraviolet B-induced squamous cell carcinoma number and size in an SKH-1 hairless mouse model. Mol Cancer Res 2003;1:848-54.
4. Lluria-Prevatt M, Morreale J, Gregus J, et al. Effects of perillyl alcohol on melanoma in the TPras mouse model. Cancer Epidemiol Biomarkers Prev 2002;11:573-9.
5. Ripple GH, Gould MN, Arzoomanian RZ, et al. Phase I clinical and pharmacokinetic study of perillyl alcohol administered four times a day. Clin Cancer Res 2000;6:390-6.
6. Bailey HH, Levy D, Harris LS, et al. A phase II trial of daily perillyl alcohol in patients with advanced ovarian cancer: Eastern Cooperative Oncology Group Study E2E96. Gynecol Oncol 2002;85:464-8.
7. Meadows SM, Mulkerin D, Berlin J, et al. Phase II trial of perillyl alcohol in patients with metastatic colorectal cancer. Int J Gastrointest Cancer 2002;32:125-8.
8. Bailey HH, Attia S, Love RR, et al. Phase II trial of daily oral perillyl alcohol (NSC 641066) in treatment-refractory metastatic breast cancer. Cancer Chemother Pharmacol 2008;62:149-57.
9. Stratton S, Saboda K, Myrdal PB, et al. Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer. Nutr Cancer 2008;60:325-30.
10. Gupta A, Myrdal PB. Development of a perillyl alcohol topical cream formulation. Int J Pharm 2004;269:373-83.
11. Gupta A, Stratton SP, Myrdal PB, Gupta A, Stratton SP, Myrdal PB. An HPLC method for quantitation of perillyl alcohol in a topical pharmaceutical cream formulation. J Pharm Biomed Anal 2005;37: 447-52.
12. Bozzo P, Saboda K, Einspahr JG, et al. Reliability and validity of a histologic score as a marker for skin cancer chemoprevention studies. Anal Quant Cytol Histol 2003;25:285-92.
13. Bartels PH, Krouse RS, Prasad AR, et al. Actinic damage in histopathologically normal skin. Anal Quant Cytol Histol 2008;30:316-22.
14. Kruskal W, Wallis W. Use of ranks on one-criterion variance analysis. J Am Stat Assoc 1952;47:583-621; addendum 48:907-11.
15. Genchi H, Mori K. Evaluation and feature extraction on automatic pattern recognition system. Denki Tsuchin Gakkai Pari (in Japanese) 1965;1:1-6.
16. Fleiss J. Statistical methods for rates and proportions. New York: Wiley; 1981.
17. Bartels P, Olson G. Computer analysis of lymphocyte images. In: Catsimpoolas N, editor. Methods of cell separation. 1980. New York: Plenum Press; 2005, p. 1-99.
18. Alberts D, Ranger-Moore J, Stratton S, et al. Safety and efficacy study of dose intensive oral vitamin A in participants with sun damaged skin. Clin Cancer Res 2004;10:1875-80.
19. Alberts DS, Dorr RT, Einspahr JG, et al. Chemoprevention of human actinic keratoses by topical 2-(difluoromethyl)-dl-ornithine. Cancer Epidemiol Biomarkers Prev 2000;9:1281-6.
20. Bartels P, Yozwiak M, Einspahr JG, et al. Chemopreventive efficacy of topical difluoromethylornithine and/or triamcinolone in the treatment of actinic keratoses analyzed by karyometry. AQCH 2009;31: 355-66.
21. Bartels PH, Yozwiak ML, Bartels HG, et al. Limits of detection of chemopreventive efficacy: karyometry of skin biopsies. Cancer Epidemiol Biomarkers Prev 2008;17:1689-95.
22. Frank DH, Kimler BF, Fabian CJ, et al. Digital image analysis of breast epithelial cells collected by random periareolar fine-needle aspirates (RPFNA) from women at high risk for breast cancer taking hormone replacement and the aromatase inhibitor, letrozole, for six months. Breast Cancer Res Treat 2009;115:661-8.
23. Bartels PH, Fabian CJ, Kimler BF, et al. Karyometry of breast epithelial cells acquired by random periareolar fine needle aspiration in women at high risk for breast cancer. Anal Quant Cytol Histol 2007;29:63-70.
24. Jacobson EL, Kim H, Kim M, et al. A topical lipophilic niacin derivative increases NAD, epidermal differentiation and barrier function in photodamaged skin. Exp Dermatol 2007;16:490-9.
25. Jacobson EL, Kim M, Kim H, Wondrak GT, Jacobson MK. Developing topical prodrugs for skin cancer prevention. In: Alberts D, Hess L, editors. Fundamentals of cancer prevention. Berlin-Heidelberg: Springer-Verlag.