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Volumn 35, Issue 33, 2017, Pages 3781-3787

Modernizing clinical trial eligibility: Recommendations of the American society of clinical oncology-friends of cancer research minimum age working group

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE LYMPHOBLASTIC LEUKEMIA; AGE; ARTICLE; CANCER RESEARCH; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL (TOPIC); DRUG RESEARCH; HODGKIN DISEASE; HUMAN; MEDICAL SOCIETY; MELANOMA; PATIENT SAFETY; PATIENT SELECTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SARCOMA; MEDICAL RESEARCH; ONCOLOGY; PROCEDURES; UNITED STATES;

EID: 85034439657     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2017.74.4144     Document Type: Article
Times cited : (66)

References (41)
  • 1
    • 84929133921 scopus 로고    scopus 로고
    • Improving the outcome for children with cancer: Development of targeted new agents
    • Adamson PC: Improving the outcome for children with cancer: Development of targeted new agents. CA Cancer J Clin 65:212-220, 2015
    • (2015) CA Cancer J Clin , vol.65 , pp. 212-220
    • Adamson, P.C.1
  • 2
    • 84891418810 scopus 로고    scopus 로고
    • Leading causes for 2010
    • Heron M: Leading causes for 2010. Natl Vital Stat Rep 62:1-96, 2013
    • (2013) Natl Vital Stat Rep , vol.62 , pp. 1-96
    • Heron, M.1
  • 4
    • 0141462439 scopus 로고    scopus 로고
    • Health status of adult long-term survivors of childhood cancer: A report from the Childhood Cancer Survivor Study
    • Hudson MM, Mertens AC, Yasui Y, et al: Health status of adult long-term survivors of childhood cancer: A report from the Childhood Cancer Survivor Study. JAMA 290:1583-1592, 2003
    • (2003) JAMA , vol.290 , pp. 1583-1592
    • Hudson, M.M.1    Mertens, A.C.2    Yasui, Y.3
  • 5
    • 0038688418 scopus 로고    scopus 로고
    • Late effects of childhood cancer therapy
    • Bottomley SJ, Kassner E: Late effects of childhood cancer therapy. J Pediatr Nurs 18:126-133, 2003
    • (2003) J Pediatr Nurs , vol.18 , pp. 126-133
    • Bottomley, S.J.1    Kassner, E.2
  • 7
    • 84941370336 scopus 로고    scopus 로고
    • Modernizing eligibility criteria for molecularly driven trials
    • Kim ES, Bernstein D, Hilsenbeck SG, et al: Modernizing eligibility criteria for molecularly driven trials. J Clin Oncol 33:2815-2820, 2015
    • (2015) J Clin Oncol , vol.33 , pp. 2815-2820
    • Kim, E.S.1    Bernstein, D.2    Hilsenbeck, S.G.3
  • 8
    • 85018463691 scopus 로고    scopus 로고
    • Reevaluating eligibility criteria: Balancing patient protection and participation in oncology trials
    • Beaver JA, Ison G, Pazdur R: Reevaluating eligibility criteria: Balancing patient protection and participation in oncology trials. N Engl J Med 376: 1504-1505, 2017
    • (2017) N Engl J Med , vol.376 , pp. 1504-1505
    • Beaver, J.A.1    Ison, G.2    Pazdur, R.3
  • 9
    • 0038176443 scopus 로고    scopus 로고
    • Phase i trial and pharmacokinetics of fenretinide in children with neuroblastoma
    • Garaventa A, Luksch R, Lo Piccolo MS, et al: Phase I trial and pharmacokinetics of fenretinide in children with neuroblastoma. Clin Cancer Res 9: 2032-2039, 2003
    • (2003) Clin Cancer Res , vol.9 , pp. 2032-2039
    • Garaventa, A.1    Luksch, R.2    Lo Piccolo, M.S.3
  • 10
    • 14944353655 scopus 로고    scopus 로고
    • Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study
    • Puduvalli VK, Yung WKA, Hess KR, et al: Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study. J Clin Oncol 22: 4282-4289, 2004
    • (2004) J Clin Oncol , vol.22 , pp. 4282-4289
    • Puduvalli, V.K.1    Yung, W.K.A.2    Hess, K.R.3
  • 11
    • 84866934606 scopus 로고    scopus 로고
    • Activity and safety of crizotinib in patients with ALKpositive non-small-cell lung cancer: Updated results from a phase 1 study
    • Camidge DR, Bang YJ, Kwak EL, et al: Activity and safety of crizotinib in patients with ALKpositive non-small-cell lung cancer: Updated results from a phase 1 study. Lancet Oncol 13: 1011-1019, 2012
    • (2012) Lancet Oncol , vol.13 , pp. 1011-1019
    • Camidge, D.R.1    Bang, Y.J.2    Kwak, E.L.3
  • 12
    • 85007467216 scopus 로고    scopus 로고
    • First-dose and steady-state pharmacokinetics of orally administered crizotinib in children with solid tumors: A report on ADVL0912 from the Children's Oncology Group phase 1/pilot consortium
    • Balis FM, Thompson PA, Mosse YP, et al: First-dose and steady-state pharmacokinetics of orally administered crizotinib in children with solid tumors: A report on ADVL0912 from the Children's Oncology Group phase 1/pilot consortium. Cancer Chemother Pharmacol 79:181-187, 2017
    • (2017) Cancer Chemother Pharmacol , vol.79 , pp. 181-187
    • Balis, F.M.1    Thompson, P.A.2    Mosse, Y.P.3
  • 13
    • 84876966952 scopus 로고    scopus 로고
    • Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: A Children's Oncology Group phase 1 consortium study
    • Mossé YP, LimMS, Voss SD, et al: Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: A Children's Oncology Group phase 1 consortium study. Lancet Oncol 14:472-480, 2013
    • (2013) Lancet Oncol , vol.14 , pp. 472-480
    • Mossé, Y.P.1    Lim, M.S.2    Voss, S.D.3
  • 14
    • 33644690129 scopus 로고    scopus 로고
    • Pediatric phase i trials in oncology: An analysis of study conduct efficiency
    • Lee DP, Skolnik JM, Adamson PC: Pediatric phase I trials in oncology: An analysis of study conduct efficiency. J Clin Oncol 23:8431-8441, 2005
    • (2005) J Clin Oncol , vol.23 , pp. 8431-8441
    • Lee, D.P.1    Skolnik, J.M.2    Adamson, P.C.3
  • 15
    • 84873809412 scopus 로고    scopus 로고
    • Targeting developmental pathways in children with cancer: What price success?
    • Gore L, DeGregori J, Porter CC: Targeting developmental pathways in children with cancer: What price success?. Lancet Oncol 14:e70-e78, 2013
    • (2013) Lancet Oncol , vol.14 , pp. e70-e78
    • Gore, L.1    DeGregori, J.2    Porter, C.C.3
  • 16
    • 0027230568 scopus 로고
    • Ewing sarcoma 11;22 translocation produces a chimeric transcription factor that requires the DNAbinding domain encoded by FLI1 for transformation
    • May WA, Gishizky ML, Lessnick SL, et al: Ewing sarcoma 11;22 translocation produces a chimeric transcription factor that requires the DNAbinding domain encoded by FLI1 for transformation. Proc Natl Acad Sci USA 90:5752-5756, 1993
    • (1993) Proc Natl Acad Sci USA , vol.90 , pp. 5752-5756
    • May, W.A.1    Gishizky, M.L.2    Lessnick, S.L.3
  • 18
    • 0031924824 scopus 로고    scopus 로고
    • EWSFLI1 fusion transcript structure is an independent determinant of prognosis in Ewing's sarcoma
    • de Alava E, Kawai A, Healey JH, et al: EWSFLI1 fusion transcript structure is an independent determinant of prognosis in Ewing's sarcoma. J Clin Oncol 16:1248-1255, 1998
    • (1998) J Clin Oncol , vol.16 , pp. 1248-1255
    • De Alava, E.1    Kawai, A.2    Healey, J.H.3
  • 19
    • 85027162957 scopus 로고    scopus 로고
    • CD30 expression in pediatric neoplasms, study of 585 cases
    • Cheng J, Zhu H, Choi JK: CD30 expression in pediatric neoplasms, study of 585 cases. Pediatr Dev Pathol 20:191-196, 2017
    • (2017) Pediatr Dev Pathol , vol.20 , pp. 191-196
    • Cheng, J.1    Zhu, H.2    Choi, J.K.3
  • 20
    • 85006986117 scopus 로고    scopus 로고
    • Diagnostic, prognostic and therapeutic role of CD30 in lymphoma
    • Pierce JM, Mehta A: Diagnostic, prognostic and therapeutic role of CD30 in lymphoma. Expert Rev Hematol 10:29-37, 2017
    • (2017) Expert Rev Hematol , vol.10 , pp. 29-37
    • Pierce, J.M.1    Mehta, A.2
  • 21
    • 84957688772 scopus 로고    scopus 로고
    • Targeting CD30 using brentuximab vedotin in the treatment of Hodgkin lymphoma
    • Alperovich A, Younes A: Targeting CD30 using brentuximab vedotin in the treatment of Hodgkin lymphoma. Cancer J 22:23-26, 2016
    • (2016) Cancer J , vol.22 , pp. 23-26
    • Alperovich, A.1    Younes, A.2
  • 22
    • 84974707568 scopus 로고    scopus 로고
    • Expression of CD30 as a biomarker to predict response to brentuximab vedotin
    • Xu ML, Acevedo-Gadea C, Seropian S, et al: Expression of CD30 as a biomarker to predict response to brentuximab vedotin. Histopathology 69: 155-158, 2016
    • (2016) Histopathology , vol.69 , pp. 155-158
    • Xu, M.L.1    Acevedo-Gadea, C.2    Seropian, S.3
  • 23
    • 84937861700 scopus 로고    scopus 로고
    • The biology and management of systemic anaplastic large cell lymphoma
    • Hapgood G, Savage KJ: The biology and management of systemic anaplastic large cell lymphoma. Blood 126:17-25, 2015
    • (2015) Blood , vol.126 , pp. 17-25
    • Hapgood, G.1    Savage, K.J.2
  • 24
    • 85026225911 scopus 로고    scopus 로고
    • Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: Results from a phase II, single-arm, multicenter study
    • Martinelli G, Boissel N, Chevallier P, et al: Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: Results from a phase II, single-arm, multicenter study. J Clin Oncol 35:1795-1802, 2017
    • (2017) J Clin Oncol , vol.35 , pp. 1795-1802
    • Martinelli, G.1    Boissel, N.2    Chevallier, P.3
  • 25
    • 85016977306 scopus 로고    scopus 로고
    • Long-term relapse-free survival in a phase 2 study of blinatumomab for the treatment of patients with minimal residual disease in B-lineage acute lymphoblastic leukemia
    • Gökbuget N, Zugmaier G, Klinger M, et al: Long-term relapse-free survival in a phase 2 study of blinatumomab for the treatment of patients with minimal residual disease in B-lineage acute lymphoblastic leukemia. Haematologica 102:e132-e135, 2017
    • (2017) Haematologica , vol.102 , pp. e132-e135
    • Gökbuget, N.1    Zugmaier, G.2    Klinger, M.3
  • 26
    • 84926099033 scopus 로고    scopus 로고
    • Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: A multicentre, single-arm, phase 2 study
    • Topp MS, Gökbuget N, Stein AS, et al: Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: A multicentre, single-arm, phase 2 study. Lancet Oncol 16:57-66, 2015
    • (2015) Lancet Oncol , vol.16 , pp. 57-66
    • Topp, M.S.1    Gökbuget, N.2    Stein, A.S.3
  • 27
    • 85009814489 scopus 로고    scopus 로고
    • Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia
    • von Stackelberg A, Locatelli F, Zugmaier G, et al: Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol 34:4381-4389, 2016
    • (2016) J Clin Oncol , vol.34 , pp. 4381-4389
    • Von Stackelberg, A.1    Locatelli, F.2    Zugmaier, G.3
  • 28
    • 84908073316 scopus 로고    scopus 로고
    • Chimeric antigen receptor T cells for sustained remissions in leukemia
    • Maude SL, Frey N, Shaw PA, et al: Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med 371:1507-1517, 2014
    • (2014) N Engl J Med , vol.371 , pp. 1507-1517
    • Maude, S.L.1    Frey, N.2    Shaw, P.A.3
  • 29
    • 84923019006 scopus 로고    scopus 로고
    • T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: A phase 1 dose-escalation trial
    • Lee DW, Kochenderfer JN, Stetler-Stevenson M, et al: T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: A phase 1 dose-escalation trial. Lancet 385:517-528, 2015
    • (2015) Lancet , vol.385 , pp. 517-528
    • Lee, D.W.1    Kochenderfer, J.N.2    Stetler-Stevenson, M.3
  • 30
    • 85019806116 scopus 로고    scopus 로고
    • Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults
    • Gardner RA, Finney O, Annesley C, et al: Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults. Blood 129:3322-3331, 2017
    • (2017) Blood , vol.129 , pp. 3322-3331
    • Gardner, R.A.1    Finney, O.2    Annesley, C.3
  • 31
    • 84890205877 scopus 로고    scopus 로고
    • CAR-modified anti-CD19 T cells for the treatment of B-cell malignancies: Rules of the road
    • Gill S, Porter DL: CAR-modified anti-CD19 T cells for the treatment of B-cell malignancies: Rules of the road. Expert Opin Biol Ther 14:37-49, 2014
    • (2014) Expert Opin Biol Ther , vol.14 , pp. 37-49
    • Gill, S.1    Porter, D.L.2
  • 32
    • 85016288763 scopus 로고    scopus 로고
    • Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma
    • Locke FL, Neelapu SS, Bartlett NL, et al: Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther 25: 285-295, 2017
    • (2017) Mol Ther , vol.25 , pp. 285-295
    • Locke, F.L.1    Neelapu, S.S.2    Bartlett, N.L.3
  • 33
    • 85034444800 scopus 로고    scopus 로고
    • Institute of Medicine: Safe and Effective Medicines for Children, Washington, DC, The National Academies Press
    • Institute of Medicine: Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA. Washington, DC, The National Academies Press, 2012
    • (2012) Pediatric Studies Conducted under BPCA and PREA
  • 35
    • 84871467132 scopus 로고    scopus 로고
    • US Food and Drug Administration: Draft guidance for industry
    • US Food and Drug Administration: Draft guidance for industry: How to comply with the Pediatric Research Equity Act. http://www.fda.gov/ downloads/drugs/guidancecomplianceregulatory information/guidances/ucm079756.pdf
    • How to Comply with the Pediatric Research Equity Act
  • 36
    • 85034427499 scopus 로고    scopus 로고
    • Best Pharmaceuticals for Children Act (January 4) Pub Law 107-109
    • Best Pharmaceuticals for Children Act (January 4, 2002) Pub Law 107-109, 107th Congress
    • (2002) 107th Congress
  • 37
    • 85010038642 scopus 로고    scopus 로고
    • Enrolling adolescents in disease/target-appropriate adult oncology clinical trials of investigational agents
    • Chuk MK, Mulugeta Y, Roth-Cline M, et al: Enrolling adolescents in disease/target-appropriate adult oncology clinical trials of investigational agents. Clin Cancer Res 23:9-12, 2017
    • (2017) Clin Cancer Res , vol.23 , pp. 9-12
    • Chuk, M.K.1    Mulugeta, Y.2    Roth-Cline, M.3
  • 40
    • 85034423789 scopus 로고    scopus 로고
    • Phase 1/2 study of the selective TRK inhibitor larotrectinib in pediatric patients with cancer
    • (abstr TPS10577)
    • Federman N, Albert CM, Turpin B, et al: Phase 1/2 study of the selective TRK inhibitor larotrectinib in pediatric patients with cancer. J Clin Oncol 35, 2017 (suppl; abstr TPS10577)
    • (2017) J Clin Oncol , vol.35
    • Federman, N.1    Albert, C.M.2    Turpin, B.3
  • 41
    • 85028758374 scopus 로고    scopus 로고
    • The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers
    • (abstr LBA2501)
    • Hyman DM, Laetsch TW, Kummar S, et al: The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers. J Clin Oncol 35, 2017 (suppl; abstr LBA2501)
    • (2017) J Clin Oncol , vol.35
    • Hyman, D.M.1    Laetsch, T.W.2    Kummar, S.3


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