Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma

References

• Querfeld C, Guitart J, Kuzel TM, Rosen ST. Primary cutaneous lymphomas: a review with current treatment options. Blood Rev 2003;17:131–142.
   PubMed Web of Science ®Google Scholar
• Markova A, Weinstock MA. Trends in cutaneous lymphoma epidemiology. Clin Lymphoma Myeloma Leuk 2009;102(Suppl.):S63–S66.
   Google Scholar
• Whittaker SJ, Foss FM. Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma. Cancer Treat Rev 2007;33:146–160.
   PubMed Web of Science ®Google Scholar
• Ali AS, Ali S, El-Rayes BF, Philip PA, Sarkar FH. Exploitation of protein kinase C: a useful target for cancer therapy. Cancer Treat Rev 2009;35:1–8.
   PubMed Web of Science ®Google Scholar
• Mischiati C, Melloni E, Corallini F, Milani D, Bergamini C, Vaccarezza M. Potential role of PKC inhibitors in the treatment of hematological malignancies. Curr Pharm Des 2008;14:2075–2084.
   PubMed Web of Science ®Google Scholar
• Graff JR, McNulty AM, Hanna KR, et al. The protein kinase Cbeta-selective inhibitor, enzastaurin (LY317615.HCl), suppresses signaling through the AKT pathway, induces apoptosis, and suppresses growth of human colon cancer and glioblastoma xenografts. Cancer Res 2005;65:7462–7469.
   PubMed Web of Science ®Google Scholar
• Hans CP, Weisenburger DD, Greiner TC, et al. Expression of PKC-beta or cyclin D2 predicts for inferior survival in diffuse large B-cell lymphoma. Mod Pathol 2005;18:1377–1384.
   PubMed Web of Science ®Google Scholar
• Venkataraman C, Chen XC, Na S, Lee L, Neote K, Tan SL. Selective role of PKCbeta enzymatic function in regulating cell survival mediated by B cell antigen receptor cross-linking. Immunol Lett 2006;105:83–89.
   PubMed Web of Science ®Google Scholar
• Ghobrial IM, Harousseau J-L, Treon SP, et al. Enzastaurin in previously treated Waldenstrom's macroglobulemia:an open-label, multicenter, phase II study. Blood 2009;114(Suppl. 1): Abstract 3867.
   PubMed Web of Science ®Google Scholar
• Morschhauser F, Seymour JF, Kluin-Nelemans HC, et al. A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma. Ann Oncol 2008;19:247–253.
   PubMed Web of Science ®Google Scholar
• Robertson MJ, Kahl BS, Vose JM, et al. Phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol 2007;25:1741–1746.
   PubMed Web of Science ®Google Scholar
• Schwartzberg L, Hermann RC, Flinn IW, et al. Enzastaurin in patients with follicular lymphoma: results of a phase II study. J Clin Oncol 2010;28(15 Suppl.): Abstract 8040.
   Google Scholar
• Querfeld C, Rizvi MA, Kuzel TM, et al. The selective protein kinase C beta inhibitor enzastaurin induces apoptosis in cutaneous T-cell lymphoma cell lines through the AKT pathway. J Invest Dermatol 2006;126:1641–1647.
   PubMed Web of Science ®Google Scholar
• Kawauchi K, Ogasawara T, Yasuyama M, Otsuka K, Yamada O. Regulation and importance of the PI3K/Akt/mTOR signaling pathway in hematologic malignancies. Anticancer Agents Med Chem 2009;9:1024–1038.
   PubMed Web of Science ®Google Scholar
• Carducci MA, Musib L, Kies MS, et al. Phase I dose escalation and pharmacokinetic study of enzastaurin, an oral protein kinase C beta inhibitor, in patients with advanced cancer. J Clin Oncol 2006;24:4092–4099.
   PubMed Web of Science ®Google Scholar
• Kreisl TN, Kim L, Moore K, et al. A phase 1 trial of enzasataurin in patients with recurrent gliomas. Clin Cancer Res 2009;15:3617–3623.
   PubMed Web of Science ®Google Scholar
• Bunn PA Jr, Lamberg SI. Report of the Committee on Staging and Classification of Cutaneous T-Cell Lymphomas. Cancer Treat Rep 1979;63:725–728.
   PubMedGoogle Scholar
• Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas ISCL.and the cutaneous lymphoma task force of the European Organisation of Research and Treatment of Cancer (EORTC). Blood 2007;110:1713–1722. Abstract 14076.
   PubMed Web of Science ®Google Scholar
• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1–10.
   PubMedGoogle Scholar
• Welch P, Musib L, Darstein C, Baldwin J, Ayan-Oshodi M. Effects of a proton pump inhibitor (lansoprazole) and food on the bioavailability of enzastaurin administered as single oral doses to healthy subjects. J Clin Oncol 2007;25(18 Suppl.): Abstract 14076.
   Web of Science ®Google Scholar
• Olsen EA, Kim YH, Kuzel TM, et al. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol 2007;25:3109–3115.
   PubMed Web of Science ®Google Scholar
• Stevens SR, Ke MS, Parry EJ, Mark J, Cooper KD. Quantifying skin disease burden in mycosis fungoides-type cutaneous T-cell lymphomas: the severity-weighted assessment tool (SWAT). Arch Dermatol 2002;138:42–48.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999;17:1244–1253.
   PubMed Web of Science ®Google Scholar
• Jones D, Dang NH, Duvic M, Washington LT, Huh YO. Absence of CD26 expression is a useful marker for diagnosis of T-cell lymphoma in peripheral blood. Am J Clin Pathol 2001;115:885–892.
   PubMed Web of Science ®Google Scholar
• Desai NS, Poindexter GB, Monthrope YM, Bendeck SE, Swerlick RA, Chen SC. A pilot quality-of-life instrument for pruritus. J Am Acad Dermatol 2008;59:234–244.
   PubMed Web of Science ®Google Scholar
• Whittaker SJ, Demierre MF, Kim EJ, et al. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol 2010;28:4485–4491.
   PubMed Web of Science ®Google Scholar