Phase 2 trial of dasatinib in target-selected patients with recurrent glioblastoma (RTOG 0627)

Neuro-Oncology

Volumn 17, Issue 7, 2015, Pages 992-998

  Lassman, Andrew B ^a,b   Pugh, Stephanie L ^c   Gilbert, Mark R ^d,e   Aldape, Kenneth D ^d,f   Geinoz, Sandrine ^c   Beumer, Jan H ^g,h   Christner, Susan M ^g   Komaki, Ritsuko ^d   Deangelis, Lisa M ^b   Gaur, Rakesh ⁱ   Youssef, Emad ^j   Wagner, Henry ^k   Won, Minhee ^c   Mehta, Minesh P ^l  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c NRG Oncology   (United States)

^d UNIVERSITY OF TEXAS   (United States)

^e NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^f UNIVERSITY OF TORONTO   (Canada)

^g UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^h UNIVERSITY OF PITTSBURGH   (United States)

ⁱ NCI Community Oncology Research Program   (United States)

^j Arizona Oncology Services   (United States)

^k PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

^l UNIVERSITY OF MARYLAND MEDICAL SYSTEM   (United States)

more..

Author keywords

Chemotherapy; dasatinib; glioblastoma; phase II; tyrosine kinase inhibitor

Indexed keywords

ANTICONVULSIVE AGENT; BIOLOGICAL MARKER; DASATINIB; EPHRIN RECEPTOR A2; LIVER ENZYME; PLATELET DERIVED GROWTH FACTOR RECEPTOR; PROTEIN TYROSINE KINASE; STEM CELL FACTOR; TEMOZOLOMIDE; ANTINEOPLASTIC AGENT; PROTEIN KINASE INHIBITOR;

ADULT; AGED; ARTICLE; CANCER STAGING; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TARGETING; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; FEASIBILITY STUDY; FEMALE; GLIOBLASTOMA; HUMAN; HUMAN TISSUE; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; TREATMENT RESPONSE; TUMOR RECURRENCE; VERY ELDERLY; BRAIN NEOPLASMS; CLINICAL TRIAL; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; DASATINIB; GLIOBLASTOMA; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROTEIN KINASE INHIBITORS; TREATMENT OUTCOME;

EID: 84936743121     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nov011     Document Type: Article

References (41)

1. Brandes AA, Tosoni A, Amista P, et al. How effective is BCNU in recurrent glioblastoma in the modern era? A phase II trial. Neurology. 2004;63(7):1281-1284.
2. Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: An important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10(2):162-170.
3. Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol. 1999;17(8):2572-2578.
4. Ballman KV, Buckner JC, Brown PD, et al. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol. 2007;9(1):29-38.
5. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27(28):4733-4740.
6. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27(5): 740-745.
7. Quant EC, Norden AD, Drappatz J, et al. Role of a second chemotherapy in recurrent malignant glioma patients who progress on bevacizumab. Neuro Oncol. 2009;11(5):550-555.
8. Iwamoto FM, Abrey LE, Beal K, et al. Patterns of relapse and prognosis after bevacizumab failure in recurrent glioblastoma. Neurology. 2009;73(15):1200-1206.
9. Chinot OL, Wick W, Mason W, et al. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):709-722.
10. Gilbert MR, Dignam JJ, Armstrong TS, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):699-708.
11. Hunter T. Oncoprotein networks. Cell. 1997;88(3):333-346.
12. Lombardo LJ, Lee FY, Chen P, et al. Discovery of N-(2-chloro-6-methyl-phenyl)-2-(6-(4-(2-hydroxyethyl)-piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide (BMS-354825), a dual Src/Abl kinase inhibitor with potent antitumor activity in preclinical assays. J Med Chem. 2004;47(27):6658-6661.
13. Demetri GD, Lo Russo P, MacPherson IR, et al. Phase I doseescalation and pharmacokinetic study of dasatinib in patients with advanced solid tumors. Clin Cancer Res. 2009;15(19): 6232-6240.
14. Takenaka N, Mikoshiba K, Takamatsu K, et al. Immunohistochemical detection of the gene product of Rous sarcoma virus in human brain tumors. Brain Res. 1985;337(2):201-207.
15. Nister M, Libermann T, Betsholtz C, et al. Expression of messenger RNAs for platelet-derived growth factor and transforming growth factor-alpha and their receptors in human malignant glioma cell lines. Cancer Res. 1988;48(14):3910-3918.
16. Joensuu H, Puputti M, Sihto H, et al. Amplification of genes encoding KIT, PDGFRalpha and VEGFR2 receptor tyrosine kinases is frequent in glioblastoma multiforme. J Pathol. 2005;207(2): 224-231.
17. Wykosky J, Gibo DM, Stanton C, et al. EphA2 as a novel molecular marker and target in glioblastoma multiforme. Mol Cancer Res. 2005;3(10):541-551.
18. Lassman AB, Holland EC. Central Nervous System Tumors. In: Holland EC, ed. Mouse Models of Human Cancer. New York: Wiley-Liss; 2004: 199-213.
19. Wen PY, Yung WK, Lamborn KR, et al. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006;12(16): 4899-4907.
20. Raymond E, Brandes AA, Dittrich C, et al. Phase II study of imatinib in patients with recurrent gliomas of various histologies: A European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008;26(28):4659-4665.
21. Deininger M, Buchdunger E, Druker BJ. The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood. 2005;105(7):2640-2653.
22. Ahluwalia MS, de Groot J, Liu WM, et al. Targeting SRC in glioblastoma tumors and brain metastases: Rationale and preclinical studies. Cancer Lett. 2010;298(2):139-149.
23. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996.
24. Karnofsky DA, Abelmann WH, Carver LF, et al. The use of the nitrogen mustards in the palliative treatment of carcinoma with particular reference to bronchogenic carcinoma. Cancer. 1948; 1(4):634-656.
25. Macdonald DR, Cascino TL, Schold SC Jr., et al. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990;8(7):1277-1280.
26. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1-10.
27. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;54(282):457-481.
28. Choe G, Horvath S, Cloughesy TF, et al. Analysis of the phosphatidylinositol 3?-kinase signaling pathway in glioblastoma patients in vivo. Cancer Res. 2003;63(11):2742-2746.
29. Simmons ML, Lamborn KR, Takahashi M, et al. Analysis of complex relationships between age, p53, epidermal growth factor receptor, and survival in glioblastoma patients. Cancer Res. 2001;61(3): 1122-1128.
30. Twardowski PW, Beumer JH, Chen CS, et al. A phase II trial of dasatinib in patients with metastatic castration-resistant prostate cancer treated previously with chemotherapy. Anticancer Drugs. 2013;24(7):743-753.
31. Franceschi E, Stupp R, van den Bent MJ, et al. EORTC 26083 phase I/II trial of dasatinib in combination with CCNU in patients with recurrent glioblastoma. Neuro Oncol. 2012; 14(12):1503-1510.
32. Reardon DA, Vredenburgh JJ, Desjardins A, et al. Phase 1 trial of dasatinib plus erlotinib in adults with recurrent malignant glioma. J Neurooncol. 2012;108(3):499-506.
33. Dai G, Pfister M, Blackwood-Chirchir A, et al. Importance of characterizing determinants of variability in exposure: Application to dasatinib in subjects with chronic myeloid leukemia. J Clin Pharmacol. 2008;48(11):1254-1269.
34. Tang SC, de Vries N, Sparidans RW, et al. Impact of P-glycoprotein (ABCB1) and breast cancer resistance protein (ABCG2) gene dosage on plasma pharmacokinetics and brain accumulation of dasatinib, sorafenib, and sunitinib. J Pharmacol Exp Ther. 2013; 346(3):486-494.
35. Agarwal S, Mittapalli RK, Zellmer DM, et al. Active efflux of Dasatinib from the brain limits efficacy against murine glioblastoma: Broad implications for the clinical use of molecularly targeted agents. Mol Cancer Ther. 2012;11(10):2183-2192.
36. Mellinghoff IK, Wang MY, Vivanco I, et al. Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors. N Engl J Med. 2005;353(19):2012-2024.
37. Sawyers CL. Making progress through molecular attacks on cancer. Cold Spring Harb Symp Quant Biol. 2005;70:479-482.
38. Pitini V, Arrigo C, Di Mirto C, et al. Response to dasatinib in a patient with SQCC of the lung harboring a discoid-receptor-2 and synchronous chronic myelogenous leukemia. Lung Cancer. 2013; 82(1):171-172.
39. Hammerman PS, Sos ML, Ramos AH, et al. Mutations in the DDR2 kinase gene identify a novel therapeutic target in squamous cell lung cancer. Cancer Discov. 2011;1(1):78-89.
40. Sen B, Peng S, Tang X, et al. Kinase-impaired BRAF mutations in lung cancer confer sensitivity to dasatinib. Sci Transl Med. 2012; 4(136):136ra170.
41. Clarke JL, Pao W, Wu N, et al. High dose weekly erlotinib achieves therapeutic concentrations in CSF and is effective in leptomeningeal metastases from epidermal growth factor receptor mutant lung cancer. J Neurooncol. 2010;99(2):283-286.