Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.
Shankar LK, Schöder H, Sharon E, Wolchok J, Knopp MV, Wahl RL, Ellingson BM, Hall NC, Yaffe MJ, Towbin AJ, Farwell MD, Pryma D, Poussaint TY, Wright CL, Schwartz L, Harisinghani M, Mahmood U, Wu AM, Leung D, de Vries EGE, Tang Y, Beach G, Reeves SA.
Lancet Oncol. 2023 Mar;24(3):e133-e143. doi: 10.1016/S1470-2045(22)00742-2.
PMID: 36858729

Case studies for overcoming challenges in using big data in cancer.
Sweeney SM, Hamadeh HK, Abrams N, Adam SJ, Brenner S, Connors DE, Davis GJ, Fiore LD, Gawel SH, Grossman RL, Hanlon SE, Hsu K, Kelloff GJ, Kirsch IR, Louv B, McGraw D, Meng F, Milgram D, Miller RS, Morgan E, Mukundan L, O’Brien T, Robbins P, Rubin EH, Salmi L, Schaller TH, Shi G, Sigman CC, Srivastava S.
Cancer Res. 2023 Jan 10:CAN-22-1277. doi: 10.1158/0008-5472.CAN-22-1277. Online ahead of print.
PMID: 36625851

Challenges to using big data in cancer.
Sweeney SM, Hamadeh HK, Abrams N, Adam SJ, Brenner S, Connors DE, Davis GJ, Fiore LD, Gawel SH, Grossman RL, Hanlon SE, Hsu K, Kelloff GJ, Kirsch IR, Louv B, McGraw D, Meng F, Milgram D, Miller RS, Morgan E, Mukundan L, O’Brien T, Robbins P, Rubin EH, Salmi L, Schaller TH, Shi G, Sigman CC, Srivastava S.
Cancer Res. 2023 Jan 10:CAN-22-1274. doi: 10.1158/0008-5472.CAN-22-1274. Online ahead of print.
PMID: 36625843

Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration.
Anderson KC, Auclair D, Adam SJ, Agarwal A, Anderson M, Avet-Loiseau H, Bustoros M, Chapman J, Connors DE, Dash A, Di Bacco A, Du L, Facon T, Flores-Montero J, Gay F, Ghobrial IM, Gormley NJ, Gupta I, Higley H, Hillengass J, Kanapuru B, Kazandjian D, Kelloff GJ, Kirsch IR, Kremer B, Landgren O, Lightbody E, Lomas OC, Lonial S, Mateos MV, Montes de Oca R, Mukundan L, Munshi NC, O’Donnell EK, Orfao A, Paiva B, Patel R, Pugh TJ, Ramasamy K, Ray J, Roshal M, Ross JA, Sigman CC, Thoren KL, Trudel S, Ulaner G, Valente N, Weiss BM, Zamagni E, Kumar SK.
Clin Cancer Res. 2021 Oct 1;27(19):5195-5212. doi: 10.1158/1078-0432.CCR-21-1059.
PMID: 34321279.

Validation of ctDNA Quality Control Materials Through a Precompetitive Collaboration of the Foundation for the National Institutes of Health.
Williams PM, Forbes T, P Lund S, Cole KD, He HJ, Karlovich C, Paweletz CP, Stetson D, Yee LM, Connors DE, Keating SM, Destenaves B, Cleveland MH, Lau CJ, Barrett JC, Kelloff GJ, McCormack RT.
JCO Precis Oncol. 2021 Jun 1;5:PO.20.00528. doi: 10.1200/PO.20.00528.
PMID: 34250423; PMCID: PMC8232894.

Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial.
Ahmed FS, Dercle L, Goldmacher GV, Yang H, Connors D, Tang Y, Karovic S, Zhao B, Carvajal RD, Robert C, Maitland ML, Oxnard GR, Schwartz LH.
Eur Radiol. 2021 Apr;31(4):1853-1862. doi: 10.1007/s00330-020-07249-y. Epub 2020 Sep 30.
PMID: 32995974.

Provider Engagement in Radiation Oncology Data Science: Workshop Report.
Jain AK, Aneja S, Fuller CD, Dicker AP, Chung C, Kim E, Kirby JS, Quon H, Lam CJK, Louv WC, Ahern C, Xiao Y, McNutt TR, Housri N, Ennis RD, Kang J, Tang Y, Higley H, Berny-Lang MA, Camphausen KA.
JCO Clin Cancer Inform. 2020 Aug;4:700-710. doi: 10.1200/CCI.20.00051.
PMID: 32755458 No abstract available.

Enhanced Detection of Treatment Effects on Metastatic Colorectal Cancer with Volumetric CT Measurements for Tumor Burden Growth Rate Evaluation.
Maitland ML, Wilkerson J, Karovic S, Zhao B, Flynn J, Zhou M, Hilden P, Ahmed FS, Dercle L, Moskowitz CS, Tang Y, Connors DE, Adam SJ, Kelloff G, Gonen M, Fojo T, Schwartz LH, Oxnard GR.
Clin Cancer Res. 2020 Dec 15;26(24):6464-6474.
PMID: 32988968

International liquid biopsy standardization alliance white paper.
Connors D, Allen J, Alvarez JD, Boyle J, Cristofanilli M, Hiller C, Keating S, Kelloff G, Leiman L, McCormack R, Merino D, Morgan E, Pantel K, Rolfo C, Serrano MJ, Pia Sanzone A, Schlange T, Sigman C, Stewart M.
Crit Rev Oncol Hematol. 2020 Dec;156:103112. doi: 10.1016/j.critrevonc.2020.103112. Epub 2020 Sep 30.
PMID: 33035734 Review.

Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol.
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS.
Lancet Oncol. 2020 Dec;21(12):1589-1601.
PMID: 33125909

Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology.
Dercle L, Connors DE, Tang Y, Adam SJ, Gönen M, Hilden P, Karovic S, Maitland M, Moskowitz CS, Kelloff G, Zhao B, Oxnard GR, Schwartz LH.
JCO Clin Cancer Inform. 2018 Dec;2:1-12.
PMID: 30652552

Opportunities and Challenges in Implementation of Multiparameter Single Cell Analysis Platforms for Clinical Translation.
Keating SM, Taylor DL, Plant AL, Litwack ED, Kuhn P, Greenspan EJ, Hartshorn CM, Sigman CC, Kelloff GJ, Chang DD, Friberg G, Lee JSH, Kuida K.
Clin Transl Sci. 2018 May;11(3):267-276. Epub 2018 Mar 2. Review.
PMID: 29498218

Association of Minimal Residual Disease With Clinical Outcome in Pediatric and Adult Acute Lymphoblastic Leukemia: A Meta-analysis.
Berry DA, Zhou S, Higley H, Mukundan L, Fu S, Reaman GH, Wood BL, Kelloff GJ, Jessup JM, Radich JP.
JAMA Oncol. 2017 Jul 13;3(7):e170580. Epub 2017 Jul 13.
PMID: 28494052

 A QA Program for MRD Testing Demonstrates that Systematic Education can Reduce Discordance Among Experienced Interpreters.
Keeney M, Wood BL, Hedley BD, DiGiuseppe JA, Stetler-Stevenson M, Paietta E, Lozanski G, Seegmiller AC, Greig BW, Shaver AC, Mukundan L, Higley HR, Sigman CC, Kelloff G, Jessup JM, Borowitz MJ.
Cytometry B Clin Cytom. 2018 Mar;94(2):239-249. Epub 2017 May 5.
PMID: 28475275

 The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications.
Anderson KC, Auclair D, Kelloff GJ, Sigman CC, Avet-Loiseau H, Farrell AT, Gormley NJ, Kumar SK, Landgren O, Munshi NC, Cavo M, Davies FE, Di Bacco A, Dickey JS, Gutman SI, Higley HR, Hussein MA, Jessup JM, Kirsch IR, Little RF, Loberg RD, Lohr JG, Mukundan L, Omel JL, Pugh TJ, Reaman GH, Robbins MD, Sasser AK, Valente N, Zamagni E. Clin Cancer Res.
2017 Aug 1;23(15):3980-3993. Epub 2017 Apr 20.
PMID: 28428191

Lessons Learned: Transfer of the High-definition Circulating Tumor Cell Assay Platform to Development as a Commercialized Clinical Assay Platform.
Kuhn P, Keating SM, Baxter GT, Thomas K, Kolatkar A, Sigman CC.
Clin Pharmacol Ther. 2017 Nov;102(5):777-785. Epub 2017 Mar 22. Review.
PMID: 28160285

The National Cancer Institute’s PREVENT Cancer Preclinical Drug Development Program: overview, current projects, animal models, agent development strategies, and molecular targets.
Shoemaker RH, Suen CS, Holmes CA, Fay JR, Steele VE.
Semin Oncol. 2016 Feb;43(1):189-97. Epub 2015 Sep 8. Review.
PMID: 26970137

Strategies to meet precision medicine challenges in oncology – Genomics Plus.
Kelloff GJ, Sigman CC.
DIA Global Forum 2015 Jun;7(3):28-34.
PMID: N/A

Predictive Value Tools as an Aid in Chemopreventive Agent Development.
Dunn BK, Steele VE, Fagerstrom RM, Topp CF, Ransohoff D, Cunningham C, Lubet R, Ford LG, Kramer BS.
J Natl Cancer Inst. 2015 Sep 28;107(12). pii: djv259. Print 2015 Dec.
PMID: 26420882

Biomarker development in the context of urologic cancers.
Kelloff GJ, Sigman CC, Scher HI.
Urol Oncol. 2015 Jun;33(6):295-301. Epub 2015 Mar 5. Review.
PMID: 25746942

Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.
Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA.
Clin Cancer Res. 2015 Apr 1;21(7):1514-24. Epub 2015 Feb 13.
PMID: 25680375

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.
Parkinson DR, McCormack RT, Keating SM, Gutman SI, Hamilton SR, Mansfield EA, Piper MA, Deverka P, Frueh FW, Jessup JM, McShane LM, Tunis SR, Sigman CC, Kelloff GJ.
Clin Cancer Res. 2014 Mar 15;20(6):1428-44.
PMID: 24634466

Germline variants and advanced colorectal adenomas: adenoma prevention with celecoxib trial genome-wide association study.
Wang J, Carvajal-Carmona LG, Chu JH, Zauber AG; APC Trial Collaborators, Kubo M, Matsuda K, Dunlop M, Houlston RS, Sieber O, Lipton L, Gibbs P, Martin NG, Montgomery GW, Young J, Baird PN, Ratain MJ, Nakamura Y, Weiss ST, Tomlinson I, Bertagnolli MM.
Clin Cancer Res. 2013 Dec 1;19(23):6430-7. Epub 2013 Oct 1.
PMID: 24084763

Considerations in the development of circulating tumor cell technology for clinical use.
Parkinson DR, Dracopoli N, Petty BG, Compton C, Cristofanilli M, Deisseroth A, Hayes DF, Kapke G, Kumar P, Lee JSh, Liu MC, McCormack R, Mikulski S, Nagahara L, Pantel K, Pearson-White S, Punnoose EA, Roadcap LT, Schade AE, Scher HI, Sigman CC, Kelloff GJ.
J Transl Med. 2012 Jul 2;10:138. Review.
PMID: 22747748

Cancer biomarkers: selecting the right drug for the right patient.
Kelloff GJ, Sigman CC.
Nat Rev Drug Discov. 2012 Feb 10;11(3):201-14. Review.
PMID: 22322254

Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.
Meyskens FL Jr, Curt GA, Brenner DE, Gordon G, Herberman RB, Finn O, Kelloff GJ, Khleif SN, Sigman CC, Szabo E; C-Change Chemoprevention Clinical Trials and Biomarkers Subcommittee.
Cancer Prev Res (Phila). 2011 Mar;4(3):311-23.
PMID: 21372031

Statin use and colorectal adenoma risk: results from the adenoma prevention with celecoxib trial.
Bertagnolli MM, Hsu M, Hawk ET, Eagle CJ, Zauber AG; Adenoma Prevention with Celecoxib (APC) Study Investigators.
Cancer Prev Res (Phila). 2010 May;3(5):588-96. Epub 2010 Apr 19.
PMID: 20403998

A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment.
Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI.
J Natl Cancer Inst. 2009 Nov 4;101(21):1453-63. Epub 2009 Oct 23.
PMID: 19855077

I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.
Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ.
Clin Pharmacol Ther. 2009 Jul;86(1):97-100. Epub 2009 May 13.
PMID: 19440188

Challenges in clinical prostate cancer: role of imaging.
Kelloff GJ, Choyke P, Coffey DS; Prostate Cancer Imaging Working Group.
AJR Am J Roentgenol. 2009 Jun;192(6):1455-70.
PMID: 19457806

Early detection of oral neoplasia: watching with new eyes.
Kelloff GJ, Sigman CC, Contag CH.
Cancer Prev Res (Phila). 2009 May;2(5):405-8. Epub 2009 Apr 28. Review. No abstract available.
PMID: 19401527

Energy homeostasis and cancer prevention: the AMP-activated protein kinase.
Fay JR, Steele V, Crowell JA.
Cancer Prev Res (Phila). 2009 Apr;2(4):301-9. Epub 2009 Mar 31. Review.
PMID: 19336731

Five-year efficacy and safety analysis of the Adenoma Prevention with Celecoxib Trial.
Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Breazna A, Kim K, Tang J, Rosenstein RB, Umar A, Bagheri D, Collins NT, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Hawk ET; Adenoma Prevention with Celecoxib Study Investigators.
Cancer Prev Res (Phila). 2009 Apr;2(4):310-21. Epub 2009 Mar 31.
PMID: 19336730

Targeting the AKT protein kinase for cancer chemoprevention.
Crowell JA, Steele VE, Fay JR.
Mol Cancer Ther. 2007 Aug;6(8):2139-48. Review.
PMID: 17699713

The mammalian target of rapamycin pathway as a potential target for cancer chemoprevention.
Kopelovich L, Fay JR, Sigman CC, Crowell JA.
Cancer Epidemiol Biomarkers Prev. 2007 Jul;16(7):1330-40. Review.
PMID: 17626998

Assessing intraepithelial neoplasia and drug safety in cancer-preventive drug development.
Kelloff GJ, Sigman CC.
Nat Rev Cancer. 2007 Jul;7(7):508-18. Review.
PMID: 17568791

FDG-PET lymphoma demonstration project invitational workshop.
Kelloff GJ, Sullivan DM, Wilson W, Cheson B, Juweid M, Mills GQ, Zelenetz AD, Horning SJ, Weber W, Sargent DJ, Dodd L, Korn E, Armitage J, Schilsky R, Christian M, O’connor OA, Wang SJ, Farrell AT, Pazdur R, Graham M, Wahl RL, Larson SM, Kostakoglu L, Daube-Witherspoon M, Gastonis C, Siegel BA, Shankar LK, Lee DB, Higley HR, Sigman CC, Carucci D, Timko D, deGennaro LJ, Sigal E, Barker A, Woodcock J.
Acad Radiol. 2007 Mar;14(3):330-9.
PMID: 17307666

Workshop on imaging science development for cancer prevention and preemption.
Kelloff GJ, Sullivan DC, Baker H, Clarke LP, Nordstrom R, Tatum JL, Dorfman GS, Jacobs P, Berg CD, Pomper MG, Birrer MJ, Tempero M, Higley HR, Petty BG, Sigman CC, Maley C, Sharma P, Wax A, Ginsberg GG, Dannenberg AJ, Hawk ET, Messing EM, Grossman HB, Harisinghani M, Bigio IJ, Griebel D, Henson DE, Fabian CJ, Ferrara K, Fantini S, Schnall MD, Zujewski JA, Hayes W, Klein EA, DeMarzo A, Ocak I, Ketterling JA, Tempany C, Shtern F, Parnes HL, Gomez J, Srivastava S, Szabo E, Lam S, Seibel EJ, Massion P, McLennan G, Cleary K, Suh R, Burt RW, Pfeiffer RM, Hoffman JM, Roy HK, Wang T, Limburg PJ, El-Deiry WS, Papadimitrakopoulou V, Hittelman WN, MacAulay C, Veltri RW, Solomon D, Jeronimo J, Richards-Kortum R, Johnson KA, Viner JL, Stratton SP, Rajadhyaksha M, Dhawan A; Workshop Program Committee.
Cancer Biomark. 2007;3(1):1-33.
PMID: 17655039

Celecoxib for the prevention of sporadic colorectal adenomas.
Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET; APC Study Investigators.
N Engl J Med. 2006 Aug 31;355(9):873-84.
PMID: 16943400

Imaging and oncologic drug development.
El-Deiry WS, Sigman CC, Kelloff GJ.
J Clin Oncol. 2006 Jul 10;24(20):3261-73. Review.
PMID: 16829650

Progress in chemoprevention drug development: the promise of molecular biomarkers for prevention of intraepithelial neoplasia and cancer–a plan to move forward.
Kelloff GJ, Lippman SM, Dannenberg AJ, Sigman CC, Pearce HL, Reid BJ, Szabo E, Jordan VC, Spitz MR, Mills GB, Papadimitrakopoulou VA, Lotan R, Aggarwal BB, Bresalier RS, Kim J, Arun B, Lu KH, Thomas ME, Rhodes HE, Brewer MA, Follen M, Shin DM, Parnes HL, Siegfried JM, Evans AA, Blot WJ, Chow WH, Blount PL, Maley CC, Wang KK, Lam S, Lee JJ, Dubinett SM, Engstrom PF, Meyskens FL Jr, O’Shaughnessy J, Hawk ET, Levin B, Nelson WG, Hong WK; AACR Task Force on Cancer Prevention.
Clin Cancer Res. 2006 Jun 15;12(12):3661-97. Review.
PMID: 16778094

The progress and promise of molecular imaging probes in oncologic drug development.
Kelloff GJ, Krohn KA, Larson SM, Weissleder R, Mankoff DA, Hoffman JM, Link JM, Guyton KZ, Eckelman WC, Scher HI, O’Shaughnessy J, Cheson BD, Sigman CC, Tatum JL, Mills GQ, Sullivan DC, Woodcock J.
Clin Cancer Res. 2005 Nov 15;11(22):7967-85. Review.
PMID: 16299226

Correlation of in vitro chemopreventive efficacy data from the human epidermal cell assay with animal efficacy data and clinical trial plasma levels.
Elmore E, Siddiqui S, Navidi M, Steele VE, Redpath JL.
J Cell Biochem. 2005 Jun 1;95(3):571-88.
PMID: 15786488

Progress and promise of FDG-PET imaging for cancer patient management and oncologic drug development.
Kelloff GJ, Hoffman JM, Johnson B, Scher HI, Siegel BA, Cheng EY, Cheson BD, O’shaughnessy J, Guyton KZ, Mankoff DA, Shankar L, Larson SM, Sigman CC, Schilsky RL, Sullivan DC.
Clin Cancer Res. 2005 Apr 15;11(8):2785-808. Review.
PMID: 15837727

Targeting epigenetic regulatory mechanisms in cancer chemoprevention.
Fay JR, Crowell JA, Kopelovich L.
Expert Opin Ther Targets. 2005 Apr;9(2):315-28. Review.
PMID: 15934918

New science-based endpoints to accelerate oncology drug development.
Kelloff GJ, Sigman CC.
Eur J Cancer. 2005 Mar;41(4):491-501. Epub 2005 Jan 22. Review.
PMID: 15737552

Use of CA-125 in clinical trial evaluation of new therapeutic drugs for ovarian cancer.
Rustin GJ, Bast RC Jr, Kelloff GJ, Barrett JC, Carter SK, Nisen PD, Sigman CC, Parkinson DR, Ruddon RW.
Clin Cancer Res. 2004 Jun 1;10(11):3919-26. Review. No abstract available.
PMID: 15173101

Colorectal adenomas: a prototype for the use of surrogate end points in the development of cancer prevention drugs.
Kelloff GJ, Schilsky RL, Alberts DS, Day RW, Guyton KZ, Pearce HL, Peck JC, Phillips R, Sigman CC.
Clin Cancer Res. 2004 Jun 1;10(11):3908-18. Review. No abstract available.
PMID: 15173100

Reanalysis of cancer drugs: old drugs, new tricks.
Vande Woude GF, Kelloff GJ, Ruddon RW, Koo HM, Sigman CC, Barrett JC, Day RW, Dicker AP, Kerbel RS, Parkinson DR, Slichenmyer WJ.
Clin Cancer Res. 2004 Jun 1;10(11):3897-907. Review. No abstract available.
PMID: 15173099

Rationale for biomarkers and surrogate end points in mechanism-driven oncology drug development.
Park JW, Kerbel RS, Kelloff GJ, Barrett JC, Chabner BA, Parkinson DR, Peck J, Ruddon RW, Sigman CC, Slamon DJ.
Clin Cancer Res. 2004 Jun 1;10(11):3885-96. Review. No abstract available.
PMID: 15173098

Biomarkers, surrogate end points, and the acceleration of drug development for cancer prevention and treatment: an update prologue.
Kelloff GJ, Bast RC Jr, Coffey DS, D’Amico AV, Kerbel RS, Park JW, Ruddon RW, Rustin GJ, Schilsky RL, Sigman CC, Vande Woude GF.
Clin Cancer Res. 2004 Jun 1;10(11):3881-4. Review. No abstract available.
PMID: 15173097

The epigenome as a target for cancer chemoprevention.
Kopelovich L, Crowell JA, Fay JR.
J Natl Cancer Inst. 2003 Dec 3;95(23):1747-57. Review.
PMID: 14652236

Fenretinide: a prototype cancer prevention drug.
Malone W, Perloff M, Crowell J, Sigman C, Higley H.
Expert Opin Investig Drugs. 2003 Nov;12(11):1829-42. Review.
PMID: 14585058

Is inducible nitric oxide synthase a target for chemoprevention?
Crowell JA, Steele VE, Sigman CC, Fay JR.
Mol Cancer Ther. 2003 Aug;2(8):815-23. Review.
PMID: 12939472

Counterpoint: Because some surrogate end point biomarkers measure the neoplastic process they will have high utility in the development of cancer chemopreventive agents against sporadic cancers.
Kelloff GJ, O’Shaughnessy JA, Gordon GB, Hawk ET, Sigman CC.
Cancer Epidemiol Biomarkers Prev. 2003 Jul;12(7):593-6. No abstract available.
PMID: 12869396

Vitamin D and vitamin D analogs as cancer chemopreventive agents.
Guyton KZ, Kensler TW, Posner GH.
Nutr Rev. 2003 Jul;61(7):227-38. Review.
PMID: 12918875

Chemoprevention strategies in the prostate: an overview.
Kelloff GJ, Higley HR, Brawer MK, Lucia MS, Sigman CC, Crawford ED.
Rev Urol. 2002 Spring;4(2):69-77.
PMID: 16985658

Peroxisome proliferator-activated receptor modulators as potential chemopreventive agents.
Kopelovich L, Fay JR, Glazer RI, Crowell JA.
Mol Cancer Ther. 2002 Mar;1(5):357-63. Review. Erratum in: Mol Cancer Ther. 2002 May;1(7):564.
PMID: 12489852

Treatment and prevention of intraepithelial neoplasia: an important target for accelerated new agent development.
O’Shaughnessy JA, Kelloff GJ, Gordon GB, Dannenberg AJ, Hong WK, Fabian CJ, Sigman CC, Bertagnolli MM, Stratton SP, Lam S, Nelson WG, Meyskens FL, Alberts DS, Follen M, Rustgi AK, Papadimitrakopoulou V, Scardino PT, Gazdar AF, Wattenberg LW, Sporn MB, Sakr WA, Lippman SM, Von Hoff DD.
Clin Cancer Res. 2002 Feb;8(2):314-46.
PMID: 11839647

Agents, biomarkers, and cohorts for chemopreventive agent development in prostate cancer.
Kelloff GJ, Lieberman R, Steele VE, Boone CW, Lubet RA, Kopelovich L, Malone WA, Crowell JA, Higley HR, Sigman CC.
Urology. 2001 Apr;57(4 Suppl 1):46-51.
PMID: 11295594

Cancer chemoprevention using natural vitamin D and synthetic analogs.
Guyton KZ, Kensler TW, Posner GH.
Annu Rev Pharmacol Toxicol. 2001;41:421-42. Review.
PMID: 11264464

Surrogate end-point biomarkers in chemopreventive drug development.
Kelloff GJ, Sigman CC, Hawk ET, Johnson KM, Crowell JA, Guyton KZ.
IARC Sci Publ. 2001;154:13-26. Review.
PMID: 11220652

Potential use of lipoxygenase inhibitors for cancer chemoprevention.
Steele VE, Holmes CA, Hawk ET, Kopelovich L, Lubet RA, Crowell JA, Sigman CC, Kelloff GJ.
Expert Opin Investig Drugs. 2000 Sep;9(9):2121-38. Review.
PMID: 11060797

Retinoids in chemoprevention and differentiation therapy.
Hansen LA, Sigman CC, Andreola F, Ross SA, Kelloff GJ, De Luca LM.
Carcinogenesis. 2000 Jul;21(7):1271-9. Review.
PMID: 10874003

Perspectives on surrogate end points in the development of drugs that reduce the risk of cancer.
Kelloff GJ, Sigman CC, Johnson KM, Boone CW, Greenwald P, Crowell JA, Hawk ET, Doody LA.
Cancer Epidemiol Biomarkers Prev. 2000 Feb;9(2):127-37. Review.
PMID: 10698472

Progress in cancer chemoprevention: development of diet-derived chemopreventive agents.
Kelloff GJ, Crowell JA, Steele VE, Lubet RA, Malone WA, Boone CW, Kopelovich L, Hawk ET, Lieberman R, Lawrence JA, Ali I, Viner JL, Sigman CC.
J Nutr. 2000 Feb;130(2S Suppl):467S-471S. Review.
PMID: 10721931

Comparative chemopreventive mechanisms of green tea, black tea and selected polyphenol extracts measured by in vitro bioassays.
Steele VE, Kelloff GJ, Balentine D, Boone CW, Mehta R, Bagheri D, Sigman CC, Zhu S, Sharma S.
Carcinogenesis. 2000 Jan;21(1):63-7.
PMID: 10607735

Clinical development of estrogen modulators for breast cancer chemoprevention in premenopausal vs. postmenopausal women.
Lawrence JA, Malpas PB, Sigman CC, Kelloff GJ.
J Cell Biochem Suppl. 2000;34:103-14. Review.
PMID: 10762022

Cancer chemoprevention: progress and promise.
Kelloff GJ, Sigman CC, Greenwald P.
Eur J Cancer. 1999 Dec;35(14):2031-8. Review.
PMID: 10711244

Cancer chemoprevention: progress and promise.
Kelloff GJ, Sigman CC, Greenwald P.
Eur J Cancer. 1999 Dec;35(13):1755-62. Review.
PMID: 10673988

Lipoxygenase inhibitors as potential cancer chemopreventives.
Steele VE, Holmes CA, Hawk ET, Kopelovich L, Lubet RA, Crowell JA, Sigman CC, Kelloff GJ.
Cancer Epidemiol Biomarkers Prev. 1999 May;8(5):467-83. Review.
PMID: 10350444

Preclinical efficacy studies of green and black tea extracts.
Steele VE, Bagheri D, Balentine DA, Boone CW, Mehta R, Morse MA, Sharma S, Sigman CC, Stoner GD, Wargovich MJ, Weisburger JH, Zhu S, Kelloff GJ.
Proc Soc Exp Biol Med. 1999 Apr;220(4):210-2. Review. No abstract available.
PMID: 10202390

Progress in cancer chemoprevention.
Kelloff GJ, Crowell JA, Steele VE, Lubet RA, Boone CW, Malone WA, Hawk ET, Lieberman R, Lawrence JA, Kopelovich L, Ali I, Viner JL, Sigman CC.
Ann N Y Acad Sci. 1999;889:1-13. Review.
PMID: 10668477

Chemoprevention of prostate cancer: concepts and strategies.
Kelloff GJ, Lieberman R, Steele VE, Boone CW, Lubet RA, Kopelovitch L, Malone WA, Crowell JA, Sigman CC.
Eur Urol. 1999;35(5-6):342-50. Review.
PMID: 10325487

Preclinical drug development paradigms for chemopreventives.
Steele VE, Boone CW, Lubet RA, Crowell JA, Holmes CA, Sigman CC, Kelloff GJ.
Hematol Oncol Clin North Am. 1998 Oct;12(5):943-61, v-vi. Review.
PMID: 9888015

Development of new cancer chemoprevention agents: role of pharmacokinetic/pharmacodynamic and intermediate endpoint biomarker monitoring.
Lieberman R, Crowell JA, Hawk ET, Boone CW, Sigman CC, Kelloff GJ.
Clin Chem. 1998 Feb;44(2):420-7.
PMID: 9474054

Aromatase inhibitors as potential cancer chemopreventives.
Kelloff GJ, Lubet RA, Lieberman R, Eisenhauer K, Steele VE, Crowell JA, Hawk ET, Boone CW, Sigman CC.
Cancer Epidemiol Biomarkers Prev. 1998 Jan;7(1):65-78. Review.
PMID: 9456245

A quantitative structure-toxicity relationships model for the dermal sensitization guinea pig maximization assay.
Enslein K, Gombar VK, Blake BW, Maibach HI, Hostynek JJ, Sigman CC, Bagheri D.
Food Chem Toxicol. 1997 Oct-Nov;35(10-11):1091-8.
PMID: 9463544

Prevention of liver cancer.
Guyton KZ, Kensler TW.
Curr Opin Oncol. 1997 Sep;9(5):492-6.
PMID: 9327229

Farnesyl protein transferase inhibitors as potential cancer chemopreventives.
Kelloff GJ, Lubet RA, Fay JR, Steele VE, Boone CW, Crowell JA, Sigman CC.
Cancer Epidemiol Biomarkers Prev. 1997 Apr;6(4):267-82. Review.
PMID: 9107432

Progress in clinical chemoprevention.
Kelloff GJ, Hawk ET, Karp JE, Crowell JA, Boone CW, Steele VE, Lubet RA, Sigman CC.
Semin Oncol. 1997 Apr;24(2):241-52. Review.
PMID: 9129692

Perspectives and progress in development of breast cancer chemopreventive drugs.
Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk ET, Steele VE, Lubet RA, Sigman CC.
Prog Clin Biol Res. 1997;396:159-83. Review. No abstract available.
PMID: 9108597

Perspectives on chemoprevention agent selection and short-term clinical prevention trials.
Kelloff GJ, Hawk ET, Crowell JA, Boone CW, Steele VE, Lubet RA, Sigman CC.
Eur J Cancer Prev. 1996 Dec;5 Suppl 2:79-85. No abstract available.
PMID: 9061299

Epidermal growth factor receptor tyrosine kinase inhibitors as potential cancer chemopreventives.
Kelloff GJ, Fay JR, Steele VE, Lubet RA, Boone CW, Crowell JA, Sigman CC.
Cancer Epidemiol Biomarkers Prev. 1996 Aug;5(8):657-66. Review.
PMID: 8824370

Mechanistic considerations in the evaluation of chemopreventive data.
Kelloff GJ, Boone CW, Steele VE, Crowell JA, Lubet RA, Greenwald P, Hawk ET, Fay JR, Sigman CC.
IARC Sci Publ. 1996;(139):203-19. Review.
PMID: 8923032

Strategy and planning for chemopreventive drug development: clinical development plans II.
Kelloff GJ, Crowell JA, Hawk ET, Steele VE, Lubet RA, Boone CW, Covey JM, Doody LA, Omenn GS, Greenwald P, Hong WK, Parkinson DR, Bagheri D, Baxter GT, Blunden M, Doeltz MK, Eisenhauer KM, Johnson K, Knapp GG, Longfellow DG, Malone WF, Nayfield SG, Seifried HE, Swall LM, Sigman CC.
J Cell Biochem Suppl. 1996;26:54-71.
PMID: 9154168

Use of in vitro assays to predict the efficacy of chemopreventive agents in whole animals.
Steele VE, Sharma S, Mehta R, Elmore E, Redpath L, Rudd C, Bagheri D, Sigman CC, Kelloff GJ.
J Cell Biochem Suppl. 1996;26:29-53.
PMID: 9154167

New agents for cancer chemoprevention.
Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet RA, Doody LA, Malone WF, Hawk ET, Sigman CC.
J Cell Biochem Suppl. 1996;26:1-28. Review.
PMID: 9154166

Risk biomarkers and current strategies for cancer chemoprevention.
Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk E, Malone WF, Steele VE, Lubet RA, Sigman CC.
J Cell Biochem Suppl. 1996;25:1-14. Review.
PMID: 9027592

Cancer chemoprevention agent development strategies for genistein.
Steele VE, Pereira MA, Sigman CC, Kelloff GJ.
J Nutr. 1995 Mar;125(3 Suppl):713S-716S.
PMID: 7884556

Strategies for phase II cancer chemoprevention trials: cervix, endometrium, and ovary.
Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk E, Steele VE, Lubet RA, Sigman CC.
J Cell Biochem Suppl. 1995;23:1-9. Review.
PMID: 8747372

Progress in cancer chemoprevention: perspectives on agent selection and short-term clinical intervention trials.
Kelloff GJ, Boone CW, Steele VE, Crowell JA, Lubet R, Sigman CC.
Cancer Res. 1994 Apr 1;54(7 Suppl):2015s-2024s. Review.
PMID: 8137331

Chemoprevention of OH-BBN-induced bladder cancer in mice by oltipraz, alone and in combination with 4-HPR and DFMO.
Moon RC, Kelloff GJ, Detrisac CJ, Steele VE, Thomas CF, Sigman CC.
Anticancer Res. 1994 Jan-Feb;14(1A):5-11.
PMID: 8166455

Chemopreventive drug development: perspectives and progress.
Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet R, Sigman CC.
Cancer Epidemiol Biomarkers Prev. 1994 Jan-Feb;3(1):85-98. Review.
PMID: 8118391

Surrogate endpoint biomarkers for phase II cancer chemoprevention trials.
Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet R, Doody LA.
J Cell Biochem Suppl. 1994;19:1-9. Review.
PMID: 7823579

Clinical development plan: calcium.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:86-109. No abstract available.
PMID: 7616756

Clinical development plan: aspirin.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:74-85. No abstract available.
PMID: 7616755

Clinical development plan: N-Acetyl-l-cysteine.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:63-73. No abstract available.
PMID: 7616754

Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:55-62.
PMID: 7616753

Preclinical efficacy evaluation of potential chemopreventive agents in animal carcinogenesis models: methods and results from the NCI Chemoprevention Drug Development Program.
Steele VE, Moon RC, Lubet RA, Grubbs CJ, Reddy BS, Wargovich M, McCormick DL, Pereira MA, Crowell JA, Bagheri D, et al.
J Cell Biochem Suppl. 1994;20:32-54. Review.
PMID: 7616752

Clinical development plan: vitamin E.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:282-99. No abstract available.
PMID: 7616751

Clinical development plan: vitamin D3 and analogs.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:268-81. No abstract available.
PMID: 7616750

Clinical development plan: tamoxifen.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:252-67. No abstract available.
PMID: 7616749

Clinical development plan: sulindac.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:240-51. No abstract available.
PMID: 7616747

Clinical development plan: Proscar.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:231-9. No abstract available.
PMID: 7616746

Clinical development plan: piroxicam.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:219-30. No abstract available.
PMID: 7616745

Clinical development plan: oltipraz.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, et al.
J Cell Biochem Suppl. 1994;20:205-18. No abstract available.
PMID: 7616744

Clinical development plan: ibuprofen.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:197-204. No abstract available.
PMID: 7616743

Clinical development plan: N-(4-hydroxyphenyl)retinamide.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:176-96. No abstract available.
PMID: 7616742

Clinical development plan: 18beta-glycyrrhetinic acid.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:166-75. No abstract available.
PMID: 7616741

Clinical development plan: 2-difluoromethylornithine (DFMO).
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:147-65. No abstract available.
PMID: 7616740

Clinical development plan: DHEA analog 8354.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:141-6. No abstract available.
PMID: 7616739

Clinical development plan: beta-carotene and other carotenoids.
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.
J Cell Biochem Suppl. 1994;20:110-140. No abstract available.
PMID: 7616738

Mechanistic considerations in chemopreventive drug development.
Kelloff GJ, Boone CW, Steele VE, Fay JR, Lubet RA, Crowell JA, Sigman CC.
J Cell Biochem Suppl. 1994;20:1-24. Review.
PMID: 7616736

Chemoprevention of OH-BBN-induced bladder cancer in mice by piroxicam.
Moon RC, Kelloff GJ, Detrisac CJ, Steele VE, Thomas CF, Sigman CC.
Carcinogenesis. 1993 Jul;14(7):1487-9.
PMID: 8330371

Development of chemopreventive agents for lung and upper aerodigestive tract cancers.
Kelloff GJ, Boone CW, Steele VK, Perloff M, Crowell J, Doody LA.
J Cell Biochem Suppl. 1993;17F:2-17. Review.
PMID: 8412195

Development of breast cancer chemopreventive drugs.
Kelloff GJ, Boone CW, Steele VE, Crowell JA, Lubet R, Doody LA, Greenwald P.
J Cell Biochem Suppl. 1993;17G:2-13. Review.
PMID: 8007699

Chemoprevention of MNU-induced mammary tumors in the mature rat by 4-HPR and tamoxifen.
Moon RC, Kelloff GJ, Detrisac CJ, Steele VE, Thomas CF, Sigman CC.
Anticancer Res. 1992 Jul-Aug;12(4):1147-53.
PMID: 1386970

Intermediate biomarkers of precancer and their application in chemoprevention.
Kelloff GJ, Malone WF, Boone CW, Steele VE, Doody LA.
J Cell Biochem Suppl. 1992;16G:15-21. Review.
PMID: 1469895

Development of chemopreventive agents for bladder cancer.
Kelloff GJ, Boone CW, Malone WF, Steele VE, Doody LA.
J Cell Biochem Suppl. 1992;16I:1-12. Review.
PMID: 1305671

Introductory remarks: development of chemopreventive agents for prostate cancer.
Kelloff GJ, Boone CW, Malone WF, Steele VE, Doody LA.
J Cell Biochem Suppl. 1992;16H:1-8. Review.
PMID: 1289663

Progress in applied chemoprevention research.
Kelloff GJ, Malone WF, Boone CW, Sigman CC, Fay JR.
Semin Oncol. 1990 Aug;17(4):438-55. Review. No abstract available.
PMID: 2143601

A systematic search for structure-activity relationships of skin sensitizers. II. Para-phenylenediamines.
Benezra C, Sigman CC, Bagheri D, Helmes CT, Maibach HI.
Semin Dermatol. 1989 Jun;8(2):88-93. No abstract available.
PMID: 2641722

Database of inhibitors of carcinogenesis.
Bagheri D, Doeltz MK, Fay JR, Helmes CT, Monasmith LA, Sigman CC.
Environmental Carcinogenesis Reviews. 1988; 6(3): 7-18.
PMID: N/A