Selected Recent Publications
Simon, RM, Freidlin, B, Rubinstein, LV, Arbuck, S, Collins, J, Christian, M, Accelerated titration designs for phase I clinical trials in oncology, JNCI 89, 1138-47, 1997.
Rubinstein, LV, Ungerleider, R, Cooperative cancer trials, in Armitage, P. and Colton, T. (eds.), Encylopedia of Biostatistics, John Wiley & Sons, Chichester, 933-941, 1998.
Rubinstein, LV, Statistical review for medical journals, guidelines for authors, in Armitage, P. and Colton, T. (eds.), Encylopedia of Biostatistics, John Wiley & Sons, Chichester, 4275-4278, 1998.
Smith, MA, Rubinstein, L, Anderson, J, Catalano, PJ, Freidlin, B, Heyn, R, Khayat, A, Krailo, M, Land, V, Miser, J, Shuster, J, Vena, D, Second report of the Cancer Therapy Evaluation Program (CTEP) monitoring plan for secondary leukemia or myelodysplastic syndrome following treatment with epipodophyllotoxins, Journal of Clinical Oncology, 17(2): 569-77, 1999.
Korn, EL, Midthune, D, Chen, TT, Rubinstein, LV, Christian, MC, Simon, RM: Commentary on Another look at two phase I clinical trial designs, Stat. in Med. 18:2691-2692, 1999.
Therasse, P, Arbuck, SG, Eisenhauer, EA, Wanders, J, Kaplan, RS, Rubinstein, L Verweij, J, van Glabbeke, M, van Oosterom, A, Christian, MC, Gwyther, SG, New guidelines to evaluate the response to treatment in solid tumors, JNCI, 92:205-16, 2000.
Rubinstein, LV, Therapeutic studies, in Kramer, B.S. and Allegra, C.J. (eds.), Understanding Clinical Trials, Hematology/Oncology Clinics of North America. W.B. Saunders Co.,14(4):849-876, 2000.
Johnson, JI, Decker, S, Zaharevitz, D, Rubinstein, LV, Schepartz, SA, Venditti, JM, Kalyandrug, S, Arbuck, SG, Christian, M, Sausville, EA, Correlations between the National Cancer Institute USA, pre-clinical models and drug activity in human clinical trials, British Journal of Cancer, 84(10):1424-31, 2001.
Rubinstein LV and Simon RM: Phase I clinical trial design. In Budman, Calvert, Rowinsky, (eds.), Handbook of Anticancer Drug Development, Elsevier, Amsterdam, 297-308, 2003.
Hunsberger, SA, Rubinstein, LV, Dancey, J, Korn, EL, Dose escalation trial designs based on a molecularly targeted endpoint, Statistics in Medicine, 24:2171-2181, 2005.
Horstmann, E, McCabe, MS, Grochow, L, Yamamoto, S, Rubinstein, L, Budd, T, Shoemaker, D, Emanuel, EJ, Grady, C, Risks and benefits of phase 1 oncology research: Evaluating response rates and toxicities 1991-2002, New England Journal of Medicine, 352:895-904, 2005.
Rubinstein, LV, Korn, EL, Freidlin, B, Hunsberger, SA, Ivy, SP, Smith, MA, Randomized phase 2 design issues and a proposal for phase 2 screening trials, Journal of Clinical Oncology, 23:7199-7206, 2005.
Korn EL, Rubinstein LV, Hunsberger SA, et al.: Clinical trial designs for cytostatic agents and agents directed at novel molecular targets. In Buolamwini JK and Adjei AA (eds.) Novel Anticancer Agents: Strategies for Discovery and Clinical Testing, pp. 366-380, Academic Press, 2006.
Dancey, J., Freidlin, B., Rubinstein, L.V., Accelerated titration designs. In Chevret, S. (ed.) Statistical Methods for Dose-Finding Experiments, pp. 91-114, Wiley Press, 2006.
Kummar, S, Kinders, R, Rubinstein, L, Parchment, RE, Murgo, AJ, Collins, J, Pickeral, O, Low, J, Steinberg, SM, Gutierrez, M, Yang, S, Helman, L, Wiltrout, R, Tomaszewski, JE and Doroshow, JH, Compressing drug development timelines in oncology using phase '0' trials, Nature Reviews Cancer 7, 131-139, 2007.
Rubinstein, L, Dancey, J, Korn, E, Smith, M, and Wright, J, Early average change in tumor size in a phase 2 trial: efficient endpoint or false promise?, Jour of the National Cancer Inst 99, 1422-23, 2007.
Kinders, R, Parchment, RE, Ji, J, Kummar, S, Murgo, AJ, Gutierrez, M, Collins, J, Rubinstein, L, Pickeral, O, Steinberg, SM, Yang, S, Hollingshead, M, Chen, A, Helman, L, Wiltrout, R, Simpson, M, Tomaszewski, JE and Doroshow JH, Phase 0 clinical trials in cancer drug development: From FDA guidance to clinical practice, Molecular Interventions 7, 325-334, 2008.
Kummar, S, Rubinstein, L, Kinders, R, Parchment, RE, Gutierrez, M, Murgo, AJ, Ji, J, Mroczkowski, B, Pickeral, O, Simpson, M, Hollingshead, M, Yang, S, Helman, L, Wiltrout, R, Collins, J, Tomaszewski, JE, Doroshow, JH, Phase 0 clinical trials: conceptions and misconceptions, The Cancer Journal 14, 133-137, 2008.
Murgo, AJ, Kummar, S, Rubinstein, L, Gutierrez, M, Collins, J, Kinders, R, Parchment, RE, Ji, J, Steinberg, SM, Yang, S, Hollingshead, M, Chen, A, Helman, L, Wiltrout, R Tomaszewski, JE, Doroshow, JH, Designing phase 0 cancer clinical trials, Clin Cancer Res 14, 3675-3682, 2008.
Dodd, LE, Korn, EL, Freidlin, B, Jaffe, CC, Rubinstein, LV, Dancey, J, Mooney, MM, Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?, Journal of Clinical Oncology 26, 3791-3796, 2008.
Kinders, RJ, Hollingshead, M, Khin, S, Rubinstein, L, Tomaszewski, JE, Doroshow, JH, Parchment, RE, and the NCI Phase 0 Clinical Trials Team, Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts, Clinical Cancer Research 14, 6877-6885, 2008.
Eisenhauer, EA, Therasse, P, Bogaerts, J, Schwartz, LH, Sargent, D, Ford, R, Dancey, J, Arbuck, S, Gwyther, S, Mooney, M, Rubinstein, L, Shankar, L, Dodd, L, Kaplan, R, Lacombe, D, Verweij, J, New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1), European Journal of Cancer 45, 228-247, 2009.
Dancey, J, Dodd, LE, Ford, R, Kaplan, R, Mooney, M, Rubinstein, L, Schwartz, LH, Shankar, L, Therasse, P, Recommendations for the assessment of progression in randomized cancer treatment trials, European Journal of Cancer 45, 281-289, 2009.
Sargent, DJ, Rubinstein, L, Schwartz, L, Dancey, JE, Gatsonis, C, Dodd, LE, Shankar, LK, Validation of novel imaging methodologies for use as cancer clinical trial endpoints, European Journal of Cancer 45, 290-299, 2009.
Rubinstein, L, Crowley, J, Ivy, P, LeBlanc, M, Sargent, D, Randomized phase II designs, Clinical Cancer Research 15, 1883-1890, 2009.
Heath, EI, LoRusso, PM, Ivy, SP, Rubinstein, L, Christian, MC, Heilbrun, LK, Theoretical and practical application of traditional and accelerated titration phase I clinical trial designs: the Wayne State University experience, Journal of Biopharmaceutical Statistics 19, 414-423, 2009.
Sill, M and Rubinstein, L, Design (and monitoring) of clinical trials with time-to-event endpoints, in Design, summarization, analysis & interpretation of clinical trials with time-to-event endpoints, ed. Peace, K., Chapman-Hall, p. 15-69, 2009.
Kummar, S, Kinders, R, Gutierrez, M, Rubinstein, L, Parchment, RE Phillips, LR, Ji, J, Monks, A, Low, J, Chen, A, Murgo, AJ, Collins, J, Steinberg, S, Eliopoulos, H, Giranda, VL, Gordon, G, Helman, L, Wiltrout, R, Tomaszewski, JE, Doroshow, JH, and the NCI Phase 0 Working Group, Phase 0 Clinical Trial of the Poly (ADP-ribose) Polymerase (PARP) Inhibitor ABT-888 in Patients With Advanced Malignancies, Journal of Clinical Oncology, 27:2705-2711, 2009.
Yang, SX, Kummar, S, Steinberg, SM, Murgo, AJ, Gutierrez, M, Rubinstein, L, Nguyen, D, Kaur, G, Chen, AP, Giranda, VL, Tomaszewski, JE, Doroshow JH, the NCI Phase 0 Working Group, Immunohistochemical detection of poly(ADP-ribose) polymerase inhibition by ABT-888 in patients with refractory solid tumors and lymphoma, Cancer Biology and Therapy, 8: 2004-2009, 2009.
Houghton, PJ, Morton, CL, Gorlick, R, Lock, RB, Carol, H, Reynolds, CP, Kang, MH, Maris, JM, Keir, ST, Kolb, EA, Wu, J, Watkins, AE, Billups, CA, Rubinstein, L, Smith, MA, Combination testing (stage 2) of rapamycin with cytotoxic agents by the Pediatric Preclinical Testing Program, Molecular Cancer Therapeutics, 9: 101-112, 2010.
Wang, LH, Pfister, TD, Parchment, RE, Kummar, S, Rubinstein, L, Evrard, YA, Gutierrez, ME, Murgo, AJ, Tomaszewski, JE, Doroshow, JH, Kinders, RJ, Monitoring drug-induced .H2AX changes as a pharmacodynamic biomarker in individual circulating tumor cells, Clinical Cancer Research, 16: 1073-1084, 2010.
Seymour, L, Ivy, P, Sargent, D, Spriggs, D, Baker, L, Rubinstein, L, Ratain, M, LeBlanc, M, Stewart, D, Crowley, J, Groshen, S, Humphrey, J, West, P, Berry, D, The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trials Task Force and the Investigational Drug Steering Committee, Clinical Cancer Research, 16: 1764-69, 2010.
Ivy, P, Siu, L, Garrett-Mayer, E, Rubinstein, L, Approaches to phase 1 clinical trial design focused on safety, efficiency and selected patient populations: a report from the Clinical Trial Design Task Force of the NCI IDSC, Clinical Cancer Research, 16: 1726-36, 2010.
Rubinstein, L, Steinberg, S, Kummar, S, Kinders, R, Parchment, R, Murgo, A, Tomaszeweski, J, Doroshow, J, Statistics of phase 0 designs, Statistics in Medicine 20, 1072-1076, 2010.
Kinders, RJ, Hollingshead, M, Lawrence, S, Ji, J, Tabb, B, Bonner, WM, Pommier, Y, Rubinstein, L, Parchment, RE, Tomaszewski, J, Doroshow, JH, and the National Cancer Institute Phase 0 Clinical Trials Team, Development of a validated immunofluorescence assay for .H2AX as a pharmacodynamic marker of topoisomerase inhibitor activity, Clinical Cancer Research 16: 5447-5457, 2010.
brb@linus.nci.nih.gov