A phase i trial of tipifarnib with radiation therapy, with and without temozolomide, for patients with newly diagnosed glioblastoma

International Journal of Radiation Oncology Biology Physics

Volumn 81, Issue 5, 2011, Pages 1422-1427

  Nghiemphu, Phioanh Leia ^a   Wen, Patrick Y ^b   Lamborn, Kathleen R ^c   Drappatz, Jan ^b   Robins, H Ian ^d   Fink, Karen ^e   Malkin, Mark G ^f   Lieberman, Frank S ^g   Deangelis, Lisa M ^f   Torres Trejo, Alejandro ^g   Chang, Susan M ^c   Abrey, Lauren ^f   Fine, Howard A ^h   Demopoulos, Alexis ^f   Lassman, Andrew B ^f   Kesari, Santosh ^b   Mehta, Minesh P ^d   Prados, Michael D ^c   Cloughesy, Timothy F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF WISCONSIN MADISON   (United States)

^e UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^g UNIVERSITY OF PITTSBURGH   (United States)

^h NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Farnesyltransferase inhibitor; Newly diagnosed glioblastoma; Radiation; Temozolomide; Tipifarnib

Indexed keywords

ANTIEPILEPTIC DRUGS; DOSE LIMITING TOXICITY; FARNESYLTRANSFERASE; INTRACRANIAL HEMORRHAGES; MAXIMUM TOLERATED DOSE; NEWLY DIAGNOSED GLIOBLASTOMA; PHASE I; PHASE II; TEMOZOLOMIDE; TIPIFARNIB;

HEAT RADIATION; RATING; TOXICITY;

RADIOTHERAPY;

ANTICONVULSIVE AGENT; ANTIHISTAMINIC AGENT; CARBAMAZEPINE; CORTICOSTEROID; ENZYME INDUCING ANTIEPILEPTIC DRUG; FOSPHENYTOIN SODIUM; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; PRIMIDONE; TEMOZOLOMIDE; TIPIFARNIB; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ANTICONVULSANT THERAPY; ARTICLE; BLOOD TOXICITY; BRAIN HEMORRHAGE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CHEMORADIOTHERAPY; COHORT ANALYSIS; CONTROLLED STUDY; DIAGNOSTIC TEST; DIZZINESS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EMBOLISM; ERYTHEMA; FATIGUE; FEMALE; GLIOBLASTOMA; GRANULOCYTOPENIA; HUMAN; INTENSITY MODULATED RADIATION THERAPY; LEUKOPENIA; LUNG EMBOLISM; LYMPHOCYTOPENIA; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PLEURITIC PAIN; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURGICAL TECHNIQUE; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT DURATION; TUMOR BIOPSY;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; CHEMORADIOTHERAPY; DACARBAZINE; FEMALE; GLIOBLASTOMA; HUMANS; MALE; MIDDLE AGED; QUINOLONES;

EID: 81855206303     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2010.07.1997     Document Type: Article

References (31)

1. D. Louis, and W. Cavenee Molecular biology of central nervous system neoplasms V. DeVita, S. Hellman, S. Rosenberg, Principles & Practice of Oncology 6th ed 2001 Lippincott Williams & Wilkins Philadelphia 2091 2100
2. P.S. Mischel, and T.F. Cloughesy Targeted molecular therapy of GBM Brain Pathol 13 2003 52 61 (Pubitemid 36133792)
3. M.M. Feldkamp, P. Lala, and N. Lau Expression of activated epidermal growth factor receptors, Ras-guanosine triphosphate, and mitogen-activated protein kinase in human glioblastoma multiforme specimens Neurosurgery 45 1999 1442 1453
4. M.M. Feldkamp, N. Lau, and J. Rak Normoxic and hypoxic regulation of vascular endothelial growth factor (VEGF) by astrocytoma cells is mediated by Ras Int J Cancer 81 1999 118 124 (Pubitemid 29124206)
5. A. Guha Ras activation in astrocytomas and neurofibromas Can J Neurol Sci 25 1998 267 281 (Pubitemid 28516920)
6. L.T. McGillicuddy, J.A. Fromm, and P.E. Hollstein Proteasomal and genetic inactivation of the NF1 tumor suppressor in gliomagenesis Cancer Cell 16 2009 44 54
7. M.M. Feldkamp, N. Lau, and L. Roncari Isotype-specific Ras.GTP-levels predict the efficacy of farnesyl transferase inhibitors against human astrocytomas regardless of Ras mutational status Cancer Res 61 2001 4425 4431 (Pubitemid 32685770)
8. C. Delmas, C. Heliez, and E. Cohen-Jonathan Farnesyltransferase inhibitor, R115777, reverses the resistance of human glioma cell lines to ionizing radiation Int J Cancer 100 2002 43 48 (Pubitemid 34602063)
9. D.W. End, G. Smets, and A.V. Todd Characterization of the antitumor effects of the selective farnesyl protein transferase inhibitor R115777 in vivo and in vitro Cancer Res 61 2001 131 137 (Pubitemid 32095710)
10. C. Delmas, D. End, and P. Rochaix The farnesyltransferase inhibitor R115777 reduces hypoxia and matrix metalloproteinase 2 expression in human glioma xenograft Clin Cancer Res 9 16 Pt 1 2003 6062 6068 (Pubitemid 38018094)
11. I.F. Pollack, M. Bredel, and M. Erff Inhibition of Ras and related guanosine triphosphate-dependent proteins as a therapeutic strategy for blocking malignant glioma growth: II-preclinical studies in a nude mouse model Neurosurgery 45 1999 1208 1214 discussion 1214-1205
12. M. Bredel, I.F. Pollack, and J.M. Freund Inhibition of Ras and related G-proteins as a therapeutic strategy for blocking malignant glioma growth Neurosurgery 43 1998 124 131 discussion 131-122
13. G. Hudes, J. Schol, and J. Baab Phase I clinical and pharmacokinetic trial of the farnesyltransferase inhibitor R115777 in a 21-day dosing schedule Proceedings of the Annual Meeting of the American Society of Clinical Oncology. J Clin Oncol 18 1999 156a Abstract no. 601
14. J. Zujewski, I.D. Horak, and C.J. Bol Phase I and pharmacokinetic study of farnesyl protein transferase inhibitor R115777 in advanced cancer J Clin Oncol 18 2000 927 941 (Pubitemid 30106625)
15. T.F. Cloughesy, J. Kuhn, and H.I. Robins Phase I trial of tipifarnib in patients with recurrent malignant glioma taking enzyme-inducing antiepileptic drugs: A North American Brain Tumor Consortium Study J Clin Oncol 23 2005 6647 6656 (Pubitemid 46190259)
16. T.F. Cloughesy, P.Y. Wen, and H.I. Robins Phase II trial of tipifarnib in patients with recurrent malignant glioma either receiving or not receiving enzyme-inducing antiepileptic drugs: A North American Brain Tumor Consortium Study J Clin Oncol 24 2006 3651 3656 (Pubitemid 46630540)
17. Kuhn J, Prados M, Robins H. Phase I trial of R115777 (Zarnestra) in patients with recurrent malignant glioma taking enzyme inducting antiepileptic drugs (EIAED): A North American Brain Tumor Consortium (NABTC) report. Presented at American Society of Clinical Oncology May 2000 New Orleans, LA.
18. J.G. Kuhn Influence of anticonvulsants on the metabolism and elimination of irinotecan: A North American Brain Tumor Consortium preliminary report Oncology (Williston Park) 16 8 Suppl. 7 2002 33 40
19. S.M. Chang, J.G. Kuhn, and H.I. Robins A Phase II study of paclitaxel in patients with recurrent malignant glioma using different doses depending upon the concomitant use of anticonvulsants: A North American Brain Tumor Consortium report Cancer 91 2001 417 422 (Pubitemid 32099244)
20. R. Stupp, W.P. Mason, and M.J. van den Bent Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma N Engl J Med 352 2005 987 996 (Pubitemid 40349501)
21. Temodar (temozolomide) [package insert]. Schering Corporation, Kenilworth, NJ, 2004.
22. L. Gore, S.N. Holden, and R.B. Cohen A phase I safety, pharmacological and biological study of the farnesyl protein transferase inhibitor, tipifarnib and capecitabine in advanced solid tumors Ann Oncol 17 2006 1709 1717 (Pubitemid 44680894)
23. T.M. Zimmerman, H. Harlin, and O.M. Odenike Dose-ranging pharmacodynamic study of tipifarnib (R115777) in patients with relapsed and refractory hematologic malignancies J Clin Oncol 22 2004 4816 4822
24. E.C. Moyal, A. Laprie, and M. Delannes Phase I trial of tipifarnib (R115777) concurrent with radiotherapy in patients with glioblastoma multiforme Int J Radiat Oncol Biol Phys 68 2007 1396 1401 (Pubitemid 47176810)
25. J.-Y. Delattre, B. Safai, and J.B. Posner Erythema multiforme and Stevens-Johnson syndrome in patients receiving cranial irradiation and phenytoin Neurology 38 1988 194 198 (Pubitemid 18036835)
26. H.J. Mamon, P.Y. Wen, and A.C. Burns Allergic skin reactions to anticonvulsant medications in patients receiving cranial radiation therapy Epilepsia 40 1999 341 344 (Pubitemid 29164800)
27. M.C.Y. de Wit, H.G. de Bruin, and W. Eijkenboom Immediate post-radiotherapy changes in malignant glioma can mimic tumor progression Neurology 63 2004 535 537 (Pubitemid 39031388)
28. A.A. Brandes, A. Tosoni, and F. Spagnolli Disease progression or pseudoprogression after concomitant radiochemotherapy treatment: Pitfalls in neurooncology Neuro Oncol 10 2008 361 367
29. D. Brandsma, L. Stalpers, and W. Taal Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas Lancet Oncol 9 2008 453 461 (Pubitemid 351597795)
30. M.C. Chamberlain, M.J. Glantz, and L. Chalmers Early necrosis following concurrent Temodar and radiotherapy in patients with glioblastoma J Neurooncol 82 2007 81 83
31. P.Y. Wen, D.R. Macdonald, and D.A. Reardon Updated response assessment criteria for high-grade gliomas: Response assessment in neuro-oncology working group J Clin Oncol 28 2010 1963 1972