Cilengitide in patients with recurrent glioblastoma: The results of NABTC 03-02, a phase II trial with measures of treatment delivery

Journal of Neuro-Oncology

Volumn 106, Issue 1, 2012, Pages 147-153

  Gilbert, Mark R ^a   Kuhn, John ^b   Lamborn, Kathleen R ^c   Lieberman, Frank ^d   Wen, Patrick Y ^e   Mehta, Minesh ^f   Cloughesy, Timothy ^g   Lassman, Andrew B ^h   Deangelis, Lisa M ^h   Chang, Susan ^c   Prados, Michael ^c  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

^e DANA FARBER CANCER INSTITUTE   (United States)

^f UNIVERSITY OF WISCONSIN MADISON   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Glioblastoma; Integrins; Pharmacokinetics; Tumor pharmacokinetics

Indexed keywords

CILENGITIDE;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER RECURRENCE; CANCER SURGERY; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG TUMOR LEVEL; ERYTHEMA MULTIFORME; FATIGUE; FEMALE; GLIOBLASTOMA; HOT FLUSH; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; INFECTION; LEUKOCYTE; LIMIT OF DETECTION; LOW DRUG DOSE; LUNG EDEMA; LYMPHOCYTOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPHIL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RASH; SIDE EFFECT; SKIN BRUISING; THROMBOCYTE; VITREOUS HEMORRHAGE; VOMITING;

ADULT; AGED; BRAIN NEOPLASMS; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; ENDPOINT DETERMINATION; FEMALE; GLIOBLASTOMA; HUMANS; IMMUNOTHERAPY; INTEGRINS; KARNOFSKY PERFORMANCE STATUS; MALE; MIDDLE AGED; RECURRENCE; SNAKE VENOMS;

EID: 83055173043     PISSN: 0167594X     EISSN: 15737373     Source Type: Journal    
DOI: 10.1007/s11060-011-0650-1     Document Type: Article

References (23)

1. KR Lamborn WK Yung SM Chang PY Wen TF Cloughesy LM DeAngelis HI Robins FS Lieberman HA Fine KL Fink L Junck L Abrey MR Gilbert M Mehta JG Kuhn KD Aldape J Hibberts PM Peterson MD Prados 2008 Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas Neuro-oncology 10 2 162 170 18356283 10.1215/15228517-2007-062
2. JF de Groot MR Gilbert 2007 New molecular targets in malignant gliomas Curr Opin Neurol 20 6 712 718 17992095 10.1097/WCO.0b013e3282f15650 (Pubitemid 350085016)
3. J Folkman 2006 Angiogenesis Annu Rev Med 57 1 1 18 16409133 10.1146/annurev.med.57.121304.131306 1:CAS:528:DC%2BD28Xis1Cksrg%3D (Pubitemid 43261975)
4. DR Senger SR Ledbetter KP Claffey A Papadopoulos-Sergiou CA Peruzzi M Detmar 1996 Stimulation of endothelial cell migration by vascular permeability factor/vascular endothelial growth factor through cooperative mechanisms involving the alphavbeta3 integrin, osteopontin, and thrombin Am J Pathol 149 1 293 305 8686754 1:CAS:528:DyaK28XkslKhtr8%3D (Pubitemid 26231000)
5. JC Tonn S Wunderlich S Kerkau CE Klein K Roosen 1998 Invasive behaviour of human gliomas is mediated by interindividually different integrin patterns Anticancer Res 18 4A 2599 2605 9703915 1:CAS:528:DyaK1cXlsF2htr8%3D (Pubitemid 28386556)
6. BP Eliceiri DA Cheresh 1999 The role of alphav integrins during angiogenesis: insights into potential mechanisms of action and clinical development J Clin Invest 103 9 1227 1230 10225964 10.1172/JCI6869 1:CAS:528:DyaK1MXivFansrs%3D (Pubitemid 29218291)
7. TV Byzova R Rabbani SE D'Souza EF Plow 1998 Role of integrin alpha(v)beta3 in vascular biology Thromb Haemost 80 5 726 734 9843163 1:CAS:528:DyaK1cXnsF2jtbg%3D (Pubitemid 28521714)
8. M Friedlander PC Brooks RW Shaffer CM Kincaid JA Varner DA Cheresh 1995 Definition of two angiogenic pathways by distinct alpha v integrins Science 270 5241 1500 1502 7491498 10.1126/science.270.5241.1500 1:CAS:528: DyaK2MXps12hs7k%3D (Pubitemid 3005294)
9. CL Gladson 1996 Expression of integrin alpha v beta 3 in small blood vessels of glioblastoma tumors J Neuropathol Exp Neurol 55 11 1143 1149 8939197 10.1097/00005072-199611000-00005 1:CAS:528:DyaK28XnsVakur8%3D (Pubitemid 26372791)
10. L Bello M Francolini P Marthyn J Zhang RS Carroll DC Nikas JF Strasser R Villani DA Cheresh PM Black 2001 Alpha(v)beta3 and alpha(v)beta5 integrin expression in glioma periphery Neurosurgery 49 2 380 389 11504114 1:STN:280:DC%2BD3MvlslOrug%3D%3D discussion 390
11. S Chatterjee A Matsumura J Schradermeier GY Gillespie 2000 Human malignant glioma therapy using anti-alpha(v)beta3 integrin agents J Neurooncol 46 2 135 144 10894366 10.1023/A:1006444300504 1:STN:280:DC%2BD3M%2Fhs1OntQ%3D%3D (Pubitemid 30352620)
12. TJ MacDonald T Taga H Shimada P Tabrizi BV Zlokovic DA Cheresh WE Laug 2001 Preferential susceptibility of brain tumors to the antiangiogenic effects of an alpha(v) integrin antagonist Neurosurgery 48 1 151 157 11152340 1:STN:280:DC%2BD3M7jvVantA%3D%3D (Pubitemid 32039837)
13. L Nabors S Rosenfeld T Mikkelsen, et al. 2004 NABTT 9911: a phase I trial of EMD 121974 for treatment of patients with recurrent malignant gliomas Neuro-oncology 6 4 379
14. D Reardon K Fink B Nabors T Cloughesy S Plotkin D Schiff J Raizer S Krueger M Picard T Mikkelsen 2007 Phase IIa trial of cilengitide (EMD121974) single-agent therapy in patients (pts) with recurrent glioblastoma (GBM): EMD 121974-009 J Clin Oncol 25 Suppl. 18 2002
15. ET Wong KR Hess MJ Gleason KA Jaeckle AP Kyritsis MD Prados VA Levin WK Yung 1999 Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials J Clin Oncol 17 8 2572 10561324 1:STN:280:DC%2BD3c%2FjtVSmsQ%3D%3D
16. FM Iwamoto LE Abrey K Beal PH Gutin MK Rosenblum VE Reuter LM DeAngelis AB Lassman 2009 Patterns of relapse and prognosis after bevacizumab failure in recurrent glioblastoma Neurology 73 15 1200 1206 19822869 10.1212/WNL. 0b013e3181bc0184 1:CAS:528:DC%2BD1MXht1antrfK
17. LB Nabors T Mikkelsen SS Rosenfeld F Hochberg NS Akella JD Fisher GA Cloud Y Zhang K Carson SM Wittemer AD Colevas SA Grossman 2007 Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma J Clin Oncol 25 13 1651 1657 17470857 10.1200/JCO.2006.06.6514 1:CAS:528:DC%2BD2sXlvFyktLY%3D (Pubitemid 46797943)
18. R Stupp B Goldbrunner B Neyns U Schlegel P Clement G Grabenbauer ME Hegi M Nippgen M Picard M Weller 2007 Phase I/IIa trial of cilengitide (EMD121974) and temozolomide with concomitant radiotherapy, followed by temozolomide and cilengitide maintenance therapy in patients (pts) with newly diagnosed glioblastoma (GBM) J Clin Oncol 25 Suppl. 18 2000
19. FA Eskens H Dumez R Hoekstra A Perschl C Brindley S Bottcher W Wynendaele J Drevs J Verweij AT van Oosterom 2003 Phase I and pharmacokinetic study of continuous twice weekly intravenous administration of Cilengitide (EMD 121974), a novel inhibitor of the integrins alphavbeta3 and alphavbeta5 in patients with advanced solid tumours Eur J Cancer 39 7 917 926 12706360 10.1016/S0959-8049(03) 00057-1 1:CAS:528:DC%2BD3sXivFCktL0%3D (Pubitemid 36428623)
20. DA Reardon KL Fink T Mikkelsen TF Cloughesy A O'Neill S Plotkin M Glantz P Ravin JJ Raizer KM Rich D Schiff WR Shapiro S Burdette-Radoux EJ Dropcho SM Wittemer J Nippgen M Picard LB Nabors 2008 Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme J Clin Oncol 26 34 5610 5617 18981465 10.1200/JCO.2008.16.7510 1:CAS:528:DC%2BD1MXmsVSrsw%3D%3D
21. TJ MacDonald CF Stewart M Kocak S Goldman RG Ellenbogen P Phillips D Lafond TY Poussaint MW Kieran JM Boyett LE Kun 2008 Phase I clinical trial of cilengitide in children with refractory brain tumors: Pediatric Brain Tumor Consortium Study PBTC-012 J Clin Oncol 26 6 919 924 18281665 10.1200/JCO.2007.14.1812 1:CAS:528:DC%2BD1cXjtFeltrg%3D (Pubitemid 351398085)
22. GD Maurer I Tritschler B Adams G Tabatabai W Wick R Stupp M Weller 2009 Cilengitide modulates attachment and viability of human glioma cells, but not sensitivity to irradiation or temozolomide in vitro Neuro-oncology 11 6 747 756 19221171 10.1215/15228517-2009-012 1:CAS:528:DC%2BC3cXotVOktg%3D%3D
23. Nabors LB, Mikkelsen T, Batchelor TT, Lesser G, Rosenfeld M, Ye X, Piantadosi S, Olson J, Brem S, Grossman SA (2009) NABTT 0306: a randomized phase II trial of EMD 121974 in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme (GBM). J Clin Oncol 27(15s):abstr. 2001