메뉴 건너뛰기




Volumn 33, Issue 28, 2015, Pages 3186-3192

Evaluation of the safety and benefit of phase I oncology trials for patients with primary CNS tumors

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; ANTINEOPLASTIC AGENT; ATRASENTAN; BORTEZOMIB; CILENGITIDE; CYTOTOXIC AGENT; DNA TOPOISOMERASE INHIBITOR; HEMOGLOBIN; INCYCLINIDE; IXABEPILONE; KARENITECAN; SORAFENIB; TEMOZOLOMIDE; TERAMEPROCOL; UNCLASSIFIED DRUG;

EID: 84944224301     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.61.1525     Document Type: Article
Times cited : (13)

References (40)
  • 2
    • 75149113069 scopus 로고    scopus 로고
    • Can molecular biomarker-based patient selection in phase I trials accelerate anticancer drug development?
    • Carden CP, Sarker D, Postel-Vinay S, et al: Can molecular biomarker-based patient selection in phase I trials accelerate anticancer drug development? Drug Discov Today 15: 88-97, 2010
    • (2010) Drug Discov Today , vol.15 , pp. 88-97
    • Carden, C.P.1    Sarker, D.2    Postel-Vinay, S.3
  • 3
    • 79959213548 scopus 로고    scopus 로고
    • Inclusion of patients with brain metastases in phase I trials: An unmet need
    • Gounder MM, Spriggs DR: Inclusion of patients with brain metastases in phase I trials: An unmet need. Clin Cancer Res 17: 3855-3857, 2011
    • (2011) Clin Cancer Res , vol.17 , pp. 3855-3857
    • Gounder, M.M.1    Spriggs, D.R.2
  • 4
    • 80051984486 scopus 로고    scopus 로고
    • It is time to include patients with brain tumors in phase I trials in oncology
    • Wen PY, Schiff D, Cloughesy TF, et al: It is time to include patients with brain tumors in phase I trials in oncology. J Clin Oncol 29: 3211-3213, 2011
    • (2011) J Clin Oncol , vol.29 , pp. 3211-3213
    • Wen, P.Y.1    Schiff, D.2    Cloughesy, T.F.3
  • 5
    • 84898545465 scopus 로고    scopus 로고
    • Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials
    • Hyman DM, Eaton AA, Gounder MM, et al: Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials. J Clin Oncol 32: 519-526, 2014
    • (2014) J Clin Oncol , vol.32 , pp. 519-526
    • Hyman, D.M.1    Eaton, A.A.2    Gounder, M.M.3
  • 6
    • 84871833722 scopus 로고    scopus 로고
    • Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials
    • Gupta S, Hunsberger S, Boerner SA, et al: Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials. J Natl Cancer Inst 104: 1860-1866, 2012
    • (2012) J Natl Cancer Inst , vol.104 , pp. 1860-1866
    • Gupta, S.1    Hunsberger, S.2    Boerner, S.A.3
  • 7
    • 14544284502 scopus 로고    scopus 로고
    • Risks and benefits of phase 1 oncology trials, 1991 through 2002
    • Horstmann E, McCabe MS, Grochow L, et al: Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352: 895-904, 2005
    • (2005) N Engl J Med , vol.352 , pp. 895-904
    • Horstmann, E.1    McCabe, M.S.2    Grochow, L.3
  • 8
    • 84857055503 scopus 로고    scopus 로고
    • Patient selection for oncology phase I trials: A multiinstitutional study of prognostic factors
    • Olmos D, A'Hern RP, Marsoni S, et al: Patient selection for oncology phase I trials: A multiinstitutional study of prognostic factors. J Clin Oncol 30: 996-1004, 2012
    • (2012) J Clin Oncol , vol.30 , pp. 996-1004
    • Olmos, D.1    A'Hern, R.P.2    Marsoni, S.3
  • 10
    • 0028334634 scopus 로고
    • Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma: Reduced local recurrence but no improvement in survival-A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group
    • Bramwell V, Rouesse J, Steward W, et al: Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma: Reduced local recurrence but no improvement in survival-A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol 12: 1137-1149, 1994
    • (1994) J Clin Oncol , vol.12 , pp. 1137-1149
    • Bramwell, V.1    Rouesse, J.2    Steward, W.3
  • 11
    • 0025281789 scopus 로고
    • Response criteria for phase II studies of supratentorial malignant glioma
    • Macdonald DR, Cascino TL, Schold SC Jr, et al: Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8: 1277-1280, 1990
    • (1990) J Clin Oncol , vol.8 , pp. 1277-1280
    • Macdonald, D.R.1    Cascino, T.L.2    Schold, S.C.3
  • 12
    • 0042967448 scopus 로고    scopus 로고
    • Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent malignant glioma
    • Gilbert MR, Supko JG, Batchelor T, et al: Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent malignant glioma. Clin Cancer Res 9: 2940-2949, 2003
    • (2003) Clin Cancer Res , vol.9 , pp. 2940-2949
    • Gilbert, M.R.1    Supko, J.G.2    Batchelor, T.3
  • 13
    • 84856271656 scopus 로고    scopus 로고
    • Phase I trial of sorafenib in patients with recurrent or progressive malignant glioma
    • Nabors LB, Supko JG, Rosenfeld M, et al: Phase I trial of sorafenib in patients with recurrent or progressive malignant glioma. Neuro Oncol 13: 1324-1330, 2011
    • (2011) Neuro Oncol , vol.13 , pp. 1324-1330
    • Nabors, L.B.1    Supko, J.G.2    Rosenfeld, M.3
  • 14
    • 20044382799 scopus 로고    scopus 로고
    • Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors
    • Strumberg D, Richly H, Hilger RA, et al: Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 23: 965-972, 2005
    • (2005) J Clin Oncol , vol.23 , pp. 965-972
    • Strumberg, D.1    Richly, H.2    Hilger, R.A.3
  • 15
    • 84859519936 scopus 로고    scopus 로고
    • Phase I study of terameprocol in patients with recurrent high-grade glioma
    • Grossman SA, Ye X, Peereboom D, et al: Phase I study of terameprocol in patients with recurrent high-grade glioma. Neuro Oncol 14: 511-517, 2012
    • (2012) Neuro Oncol , vol.14 , pp. 511-517
    • Grossman, S.A.1    Ye, X.2    Peereboom, D.3
  • 16
    • 53549093143 scopus 로고    scopus 로고
    • A phase I study of intravenous tetra-O-methyl nordihydroguaiaretic acid in patients with refractory malignancy
    • Goel S, Burris H, Mendelson D, et al: A phase I study of intravenous tetra-O-methyl nordihydroguaiaretic acid in patients with refractory malignancy. J Clin Oncol 25, 2007 (suppl 18S, abstr 3584)
    • (2007) J Clin Oncol , vol.25
    • Goel, S.1    Burris, H.2    Mendelson, D.3
  • 17
    • 0041464540 scopus 로고    scopus 로고
    • Phase I dose-escalation study of the safety and pharmacokinetics of atrasentan: An endothelin receptor antagonist for refractory prostate cancer
    • Zonnenberg BA, Groenewegen G, Janus TJ, et al: Phase I dose-escalation study of the safety and pharmacokinetics of atrasentan: An endothelin receptor antagonist for refractory prostate cancer. Clin Cancer Res 9: 2965-2972, 2003
    • (2003) Clin Cancer Res , vol.9 , pp. 2965-2972
    • Zonnenberg, B.A.1    Groenewegen, G.2    Janus, T.J.3
  • 18
    • 54049094491 scopus 로고    scopus 로고
    • Phase I and pharmacokinetic study of karenitecin in patients with recurrent malignant gliomas
    • Grossman SA, Carson KA, Phuphanich S, et al: Phase I and pharmacokinetic study of karenitecin in patients with recurrent malignant gliomas. Neuro Oncol 10: 608-616, 2008
    • (2008) Neuro Oncol , vol.10 , pp. 608-616
    • Grossman, S.A.1    Carson, K.A.2    Phuphanich, S.3
  • 19
    • 0009671162 scopus 로고    scopus 로고
    • Phase I trial of karenitecin (KT) administered intravenously daily for five consecutive days in patients with advanced solid tumor using accelerated dose titration
    • Schilsky R, Hausheer F, Bertucci D, et al: Phase I trial of karenitecin (KT) administered intravenously daily for five consecutive days in patients with advanced solid tumor using accelerated dose titration. Proc Am Soc Clin Oncol 19: 195a, 2000 (abstr 758)
    • (2000) Proc Am Soc Clin Oncol , vol.19 , pp. 195a
    • Schilsky, R.1    Hausheer, F.2    Bertucci, D.3
  • 20
    • 54049094871 scopus 로고    scopus 로고
    • Phase I safety study of escalating doses of atrasentan in adults with recurrent malignant glioma
    • Phuphanich S, Carson KA, Grossman SA, et al: Phase I safety study of escalating doses of atrasentan in adults with recurrent malignant glioma. Neuro Oncol 10: 617-623, 2008
    • (2008) Neuro Oncol , vol.10 , pp. 617-623
    • Phuphanich, S.1    Carson, K.A.2    Grossman, S.A.3
  • 21
    • 3042851918 scopus 로고    scopus 로고
    • Dose-ranging study of the safety and pharmacokinetics of atrasentan in patients with refractory malignancies
    • Ryan CW, Vogelzang NJ, Vokes EE, et al: Dose-ranging study of the safety and pharmacokinetics of atrasentan in patients with refractory malignancies. Clin Cancer Res 10: 4406-4411, 2004
    • (2004) Clin Cancer Res , vol.10 , pp. 4406-4411
    • Ryan, C.W.1    Vogelzang, N.J.2    Vokes, E.E.3
  • 22
    • 79952188360 scopus 로고    scopus 로고
    • A phase I/II trial and pharmacokinetic study of ixabepilone in adult patients with recurrent high-grade gliomas
    • Peereboom DM, Supko JG, Carson KA, et al: A phase I/II trial and pharmacokinetic study of ixabepilone in adult patients with recurrent high-grade gliomas. J Neurooncol 100: 261-268, 2010
    • (2010) J Neurooncol , vol.100 , pp. 261-268
    • Peereboom, D.M.1    Supko, J.G.2    Carson, K.A.3
  • 23
    • 0038811741 scopus 로고    scopus 로고
    • Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days
    • Abraham J, Agrawal M, Bakke S, et al: Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days. J Clin Oncol 21: 1866- 1873, 2003
    • (2003) J Clin Oncol , vol.21 , pp. 1866-1873
    • Abraham, J.1    Agrawal, M.2    Bakke, S.3
  • 24
    • 82955227413 scopus 로고    scopus 로고
    • Phase I and pharmacokinetic study of COL-3 in patients with recurrent high-grade gliomas
    • Rudek MA, New P, Mikkelsen T, et al: Phase I and pharmacokinetic study of COL-3 in patients with recurrent high-grade gliomas. J Neurooncol 105: 375-381, 2011
    • (2011) J Neurooncol , vol.105 , pp. 375-381
    • Rudek, M.A.1    New, P.2    Mikkelsen, T.3
  • 25
    • 5444229881 scopus 로고    scopus 로고
    • A phase I and pharmacokinetic study of Col-3 (Metastat), an oral tetracycline derivative with potent matrix metalloproteinase and antitumor properties
    • Syed S, Takimoto C, Hidalgo M, et al: A phase I and pharmacokinetic study of Col-3 (Metastat), an oral tetracycline derivative with potent matrix metalloproteinase and antitumor properties. Clin Cancer Res 10: 6512-6521, 2004
    • (2004) Clin Cancer Res , vol.10 , pp. 6512-6521
    • Syed, S.1    Takimoto, C.2    Hidalgo, M.3
  • 26
    • 79952194923 scopus 로고    scopus 로고
    • Phase 1 clinical trial of bortezomib in adults with recurrent malignant glioma
    • Phuphanich S, Supko JG, Carson KA, et al: Phase 1 clinical trial of bortezomib in adults with recurrent malignant glioma. J Neurooncol 100: 95-103, 2010
    • (2010) J Neurooncol , vol.100 , pp. 95-103
    • Phuphanich, S.1    Supko, J.G.2    Carson, K.A.3
  • 27
    • 0036023407 scopus 로고    scopus 로고
    • A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies
    • Aghajanian C, Soignet S, Dizon DS, et al: A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res 8: 2505-2511, 2002
    • (2002) Clin Cancer Res , vol.8 , pp. 2505-2511
    • Aghajanian, C.1    Soignet, S.2    Dizon, D.S.3
  • 28
    • 34249087162 scopus 로고    scopus 로고
    • Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma
    • Nabors LB, Mikkelsen T, Rosenfeld SS, et al: Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma. J Clin Oncol 25: 1651-1657, 2007
    • (2007) J Clin Oncol , vol.25 , pp. 1651-1657
    • Nabors, L.B.1    Mikkelsen, T.2    Rosenfeld, S.S.3
  • 29
    • 0347155579 scopus 로고    scopus 로고
    • 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
    • Eskens FA, Dumez H, Hoekstra R, et al: 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: 917-926, 2003
    • (2003) Eur J Cancer , vol.39 , pp. 917-926
    • Eskens, F.A.1    Dumez, H.2    Hoekstra, R.3
  • 30
    • 84929620816 scopus 로고    scopus 로고
    • CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2007-2011
    • suppl 4
    • Ostrom QT, Gittleman H, Liao P, et al: CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol 16: iv1-63, 2014 (suppl 4)
    • (2014) Neuro Oncol , vol.16 , pp. iv1-63
    • Ostrom, Q.T.1    Gittleman, H.2    Liao, P.3
  • 31
    • 84885074034 scopus 로고    scopus 로고
    • The somatic genomic landscape of glioblastoma
    • Brennan CW, Verhaak RG, McKenna A, et al: The somatic genomic landscape of glioblastoma. Cell 155: 462-477, 2013
    • (2013) Cell , vol.155 , pp. 462-477
    • Brennan, C.W.1    Verhaak, R.G.2    McKenna, A.3
  • 32
    • 82955195921 scopus 로고    scopus 로고
    • Revisiting the role of molecular targeted therapies in patients with brain metastases
    • Papadatos-Pastos D, Banerji U: Revisiting the role of molecular targeted therapies in patients with brain metastases. J Neurooncol 105: 467-474, 2011
    • (2011) J Neurooncol , vol.105 , pp. 467-474
    • Papadatos-Pastos, D.1    Banerji, U.2
  • 33
    • 46049110497 scopus 로고    scopus 로고
    • 90-Days mortality rate in patients treated within the context of a phase-I trial: How should we identify patients who should not go on trial?
    • Arkenau HT, Olmos D, Ang JE, et al: 90-Days mortality rate in patients treated within the context of a phase-I trial: How should we identify patients who should not go on trial? Eur J Cancer 44: 1536-1540, 2008
    • (2008) Eur J Cancer , vol.44 , pp. 1536-1540
    • Arkenau, H.T.1    Olmos, D.2    Ang, J.E.3
  • 34
    • 84938845910 scopus 로고    scopus 로고
    • Predictors of early treatment discontinuation in patients enrolled on Phase I oncology trials
    • epub ahead of print on January 21
    • Hyman DM, Eaton AA, Gounder MM, et al: Predictors of early treatment discontinuation in patients enrolled on Phase I oncology trials. Oncotarget [epub ahead of print on January 21, 2015]
    • (2015) Oncotarget
    • Hyman, D.M.1    Eaton, A.A.2    Gounder, M.M.3
  • 35
    • 0034013999 scopus 로고    scopus 로고
    • Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials
    • Bachelot T, Ray-Coquard I, Catimel G, et al: Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials. Ann Oncol 11: 151-156, 2000
    • (2000) Ann Oncol , vol.11 , pp. 151-156
    • Bachelot, T.1    Ray-Coquard, I.2    Catimel, G.3
  • 36
    • 7244243743 scopus 로고    scopus 로고
    • Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials
    • Roberts TG Jr, Goulart BH, Squitieri L, et al: Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 292: 2130-2140, 2004
    • (2004) JAMA , vol.292 , pp. 2130-2140
    • Roberts, T.G.1    Goulart, B.H.2    Squitieri, L.3
  • 37
    • 84864944854 scopus 로고    scopus 로고
    • Defining the risk of toxicity in phase I oncology trials of novel molecularly targeted agents: A single centre experience
    • Molife LR, Alam S, Olmos D, et al: Defining the risk of toxicity in phase I oncology trials of novel molecularly targeted agents: A single centre experience. Ann Oncol 23: 1968-1973, 2012
    • (2012) Ann Oncol , vol.23 , pp. 1968-1973
    • Molife, L.R.1    Alam, S.2    Olmos, D.3
  • 38
    • 9144261587 scopus 로고    scopus 로고
    • Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: A North American Brain Tumor Consortium study
    • Prados MD, Yung WK, Jaeckle KA, et al: Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: A North American Brain Tumor Consortium study. Neuro Oncol 6: 44-54, 2004
    • (2004) Neuro Oncol , vol.6 , pp. 44-54
    • Prados, M.D.1    Yung, W.K.2    Jaeckle, K.A.3
  • 39
    • 81255195686 scopus 로고    scopus 로고
    • Effect of cytochrome P450 3A4 inducers on the pharmacokinetic, pharmacodynamic and safety profiles of bortezomib in patients with multiple myeloma or non-Hodgkin's lymphoma
    • Hellmann A, Rule S, Walewski J, et al: Effect of cytochrome P450 3A4 inducers on the pharmacokinetic, pharmacodynamic and safety profiles of bortezomib in patients with multiple myeloma or non-Hodgkin's lymphoma. Clin Pharmacokinet 50: 781-791, 2011
    • (2011) Clin Pharmacokinet , vol.50 , pp. 781-791
    • Hellmann, A.1    Rule, S.2    Walewski, J.3
  • 40
    • 0034705172 scopus 로고    scopus 로고
    • Practice parameter: Anticonvulsant prophylaxis in patients with newly diagnosed brain tumors-Report of the Quality Standards Subcommittee of the American Academy of Neurology
    • Glantz MJ, Cole BF, Forsyth PA, et al: Practice parameter: Anticonvulsant prophylaxis in patients with newly diagnosed brain tumors-Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 54: 1886-1893, 2000
    • (2000) Neurology , vol.54 , pp. 1886-1893
    • Glantz, M.J.1    Cole, B.F.2    Forsyth, P.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.