Temozolomide is an active agent in children with recurrent medulloblastoma/primitive neuroectodermal tumor: An Italian multi-institutional phase II trial
Temozolomide is an active agent in children with recurrent medulloblastoma/primitive neuroectodermal tumor: An Italian multi-institutional phase II trial(369 views) Cefalo G, Massimino M, Ruggiero A, Barone G, Ridola V, Spreafico F, Potepan P, Abate ME, Mascarin M, Garrè ML, Perilongo G, Madon E, Colosimo C, Riccardi R
Keywords: Medulloblastoma, Phase Ii Trial, Temozolomide, Antiemetic Agent, Carboplatin, Cisplatin, Cyclophosphamide, Etoposide, Methotrexate, Nitrosourea Derivative, Vincristine, Adolescent, Adult, Anemia, Article, Bone Marrow Suppression, Cancer Chemotherapy, Cancer Growth, Chemotherapy Induced Nausea And Vomiting, Child, Childhood Cancer, Clinical Article, Craniospinal Irradiation, Drug Dose Reduction, Drug Efficacy, Drug Tolerability, Female, Histology, Human, Italy, Maintenance Chemotherapy, Multicenter Study, Neuroectoderm Tumor, Neutropenia, Overall Survival, Phase 2 Clinical Trial, Progression Free Survival, Thrombocytopenia, Treatment Response, Tumor Recurrence, Tumor Volume, Unspecified Side Effect,
Affiliations: *** IBB - CNR ***
Pediatrics Unit, Fondazione IRCCS, Istituto Nazionale Tumori, Milan, Italy
Pediatric Oncology, A. Gemelli Hospital, Catholic University, Rome, Italy
Department of Radiodiagnostics, Fondazione IRCCS, Istituto Nazionale Tumori, Milan, Italy
Department of Chemotherapy, Istituto Ortopedico Rizzoli, Bologna, Italy
Department of Neurosurgery, Ospedale G. Gaslini, Genova, Italy
Department of Pediatrics, University of Padua, Padua, Italy
Department of Bioimaging and Radiological Sciences, Catholic University, Rome, Italy
References: Taylor, R.E., Bailey, C.C., Robinson, K., Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The international society of paediatric oncology/united kingdom childrens cancer study group pnet-3 study (2003) J Clin Oncol, 21, pp. 1581-159
Rutkowski, S., Bode, U., Deinlein, F., Treatment of early childhood medulloblastoma by postoperative chemotherapy alone (2005) N Engl J Med, 35, pp. 2978-2986
Evans, A.E., Jenkin, R.D., Sposto, R., The treatment of medulloblastoma. Results of a prospective randomized trial of radiation therapy with and without CCNU vincristine and prednisone (1990) J Neurosurg, 72, pp. 572-582
Bailey, C.C., Gnekow, A., Wellek, S., Prospective randomised trial of chemotherapy given before radiotherapy in childhood medulloblastoma (1995) Med Pediatr Oncol, 25, pp. 166-178. , International Society of Paediatric Oncology (SIOP) and the (German) Society of Paediatric Oncology (GPO): SIOP II
Gatta, G., Capocaccia, R., Coleman, M.P., Childhood cancer survival in Europe and the United States (2002) Cancer, 95 (8), pp. 1767-1772
Dunkel, I.J., Boyett, J.M., Yates, A., High-dose carboplatin thiotepa and etoposide with autologous stem-cell rescue for patients with recurrent medulloblastoma (1998) J Clin Oncol, 16 (1), pp. 222-228. , Childrens Cancer Group
Massimino, M., Casanova, M., Polastri, D., Relapse in medulloblastoma: What can be done after abandoning high-dose chemotherapy? A mono-institutional experience (2013) Childs Nerv Syst, 29, pp. 1107-1112
Bouffet, E., Doz, F., Demaille, M.C., Improving survival in recurrent medulloblastoma: Earlier detection better treatment or still an impasse? (1998) Br J Cancer, 77, pp. 1321-1326
Gajjar, A., Pizer, B., Role of high-dose chemotherapy for recurrent medulloblastoma and other CNS primitive neuroectodermal tumors (2010) Pediatr Blood Cancer, 54 (4), pp. 649-651
Walter, A.W., Mulhern, R.K., Gajjar, A., Survival and neurodevelopmental outcome of young children with medulloblastoma at St Jude Childrens Research Hospital (1999) J Clin Oncol, 17, pp. 3720-3728
Ostermann, S., Csajka, C., Buclin, T., Plasma and cerebrospinal fluid population pharmacokinetics of temozolomide in malignant glioma patients (2004) Clin Cancer Res, 10, pp. 3728-3736
Panetta, J.C., Kirstein, M.N., Gajjar, A., Population pharmacokinetics of temozolomide and metabolites in infants and children with primary central nervous system tumors (2003) Cancer Chemother Pharmacol, 52, pp. 435-441
Patel, M., McCully, C., Godwin, K., Plasma and cerebrospinal fluid pharmacokinetics of intravenous temozolomide in non-human primates (2003) J Neurooncol, 61, pp. 203-207
Ruggiero, A., Cefalo, G., Garré, M.L., Phase II trial of temozolomide in children with recurrent high-grade glioma (2006) J Neurooncol, 77, pp. 89-94
Nicholson, H.S., Krailo, M., Ames, M.M., Phase i study of temozolomide in children and adolescents with recurrent solid tumors: A report from the Childrens Cancer Group (1998) J Clin Oncol, 16, pp. 3037-3043
Estlin, E.J., Lashford, L., Ablett, S., Phase i study of temozolomide in paediatric patients with advanced cancer (1998) Br J Cancer, 78 (5), pp. 652-661. , United Kingdom Childrens Cancer Study Group
Stevens, M.F., Hickman, J.A., Langdon, S.P., Antitumor activity and pharmacokinetics in mice of 8-carbamoyl-3-methyl- imidazo[5 i-d]-l235-tetrazin-4(3h)-one (ccrg 81045
m&b39831) a novel drug with potential as an alternative to dacarbazine (1987) Cancer Res, 47, pp. 5846-5852
Newlands, E.S., Stevens, M.F., Wedge, S.R., Temozolomide: A review of its discovery chemical properties pre-clinical development and clinical trials (1997) Cancer Treat Rev, 23 (1), pp. 35-61
Simon, R., Optimal two-stage designs for phase II clinical trials (1989) Control Clin Trials, 10, pp. 1-10
Palmer, S.L., Goloubeva, O., Reddick, W.E., Patterns of intellectual development among survivors of pediatric medulloblastoma: A longitudinal analysis (2001) J Clin Oncol, 19, pp. 2302-2308
Dunkel, I.J., Gardner, S.L., Garvin Jr., J.H., High-dose carboplatin thiotepa and etoposide with autologous stem cell rescue for patients with previously irradiated recurrent medulloblastoma (2010) Neuro Oncol, 12 (3), pp. 297-303
Grill, J., Dufour, C., Kalifa, C., High-dose chemotherapy in children with newly-diagnosed medulloblastoma (2006) Lancet Oncol, 7, pp. 787-789
Finlay, J.L., Goldman, S., Wong, M.C., Pilot study of high-dose thiotepa and etoposide with autologous bone marrow rescue in children and young adults with recurrent CNS tumors (1996) J Clin Oncol, 14, pp. 2495-2503. , The Childrens Cancer Group
Baruchel, S., Diezi, M., Hargrave, D., Safety and pharmacokinetics of temozolomide using a dose-escalation metronomic schedule in recurrent paediatric brain tumours (2006) Eur J Cancer, 42, pp. 2335-2342
De Sio, L., Milano, G.M., Castellano, A., Temozolomide in resistant or relapsed pediatric solid tumors (2006) Pediatr Blood Cancer, 47, pp. 30-36
Hongeng, S., Visudtibhan, A., Dhanachai, M., Treatment of leptomeningeal relapse of medulloblastoma with temozolomide (2002) J Pediatr Hematol Oncol, 24, pp. 591-593
Poelen, J., Bernsen, H.J., Prick, M.J., Metastatic medulloblastoma in an adult
Treatment with temozolomide (2007) Acta Neurol Belg, 107 (2), pp. 51-54
Durando, X., Thivat, E., Gilliot, O., Temozolomide treatment of an adult with a relapsing medulloblastoma (2007) Cancer Invest, 25 (6), pp. 470-475
Riccardi, A., Mazzarella, G., Cefalo, G., Pharmacokinetics of temozolomide given three times a day in pediatric and adult patients (2003) Cancer Chemother Pharmacol, 52, pp. 459-464
Sardi, I., Cetica, V., Massimino, M., Promoter methylation and expression analysis of MGMT in advanced pediatric brain tumors (2009) Oncol Rep, 22 (4), pp. 773-779
Bobola, M.S., Tseng, S.H., Blank, A., Role of O6-methylguanine-DNA methyltransferase in resistance of human brain tumor cell lines to the clinically relevant methylating agents temozolomide and streptozotocin (1996) Clin Cancer Res, 2 (4), pp. 735-741
Ruggiero, A., Rizzo, D., Attinà, G., Phase i study of temozolomide combined with oral etoposide in children with recurrent or progressive medulloblastoma (2010) Eur J Cancer, 46 (16), pp. 2943-2949
Quinn, J.A., Jiang, S.X., Reardon, D.A., Phase II trial of temozolomide (TMZ) plus irinotecan (CPT-11) in adults with newly diagnosed glioblastoma multiforme before radiotherapy (2009) J Neurooncol, 95 (3), pp. 393-400
Sasine, J.P., Savaraj, N., Feun, L.G., Topoisomerase i inhibitors in the treatment of primary CNS malignancies: An update on recent trends (2010) Anticancer Agents Med Chem, 10 (9), pp. 683-696
Lo, H.W., Cao, X., Zhu, H., Constitutively activated stat3 frequently coexpresses with epidermal growth factor receptor in high-grade gliomas and targeting stat3 sensitizes them to iressa and alkylators (2008) Clin Cancer Res, 14 (19), pp. 6042-6054
Goldhoff, P., Warrington, N.M., Limbrick Jr., D.D., Targeted inhibition of cyclic AMP phosphodiesterase-4 promotes brain tumor regression (2008) Clin Cancer Res, 14 (23), pp. 7717-7725
Taylor, R. E., Bailey, C. C., Robinson, K., Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The international society of paediatric oncology/united kingdom childrens cancer study group pnet-3 study (2003) J Clin Oncol, 21, pp. 1581-159
Evans, A. E., Jenkin, R. D., Sposto, R., The treatment of medulloblastoma. Results of a prospective randomized trial of radiation therapy with and without CCNU vincristine and prednisone (1990) J Neurosurg, 72, pp. 572-582
Bailey, C. C., Gnekow, A., Wellek, S., Prospective randomised trial of chemotherapy given before radiotherapy in childhood medulloblastoma (1995) Med Pediatr Oncol, 25, pp. 166-178. , International Society of Paediatric Oncology (SIOP) and the (German) Society of Paediatric Oncology (GPO): SIOP II
Dunkel, I. J., Boyett, J. M., Yates, A., High-dose carboplatin thiotepa and etoposide with autologous stem-cell rescue for patients with recurrent medulloblastoma (1998) J Clin Oncol, 16 (1), pp. 222-228. , Childrens Cancer Group
Walter, A. W., Mulhern, R. K., Gajjar, A., Survival and neurodevelopmental outcome of young children with medulloblastoma at St Jude Childrens Research Hospital (1999) J Clin Oncol, 17, pp. 3720-3728
Panetta, J. C., Kirstein, M. N., Gajjar, A., Population pharmacokinetics of temozolomide and metabolites in infants and children with primary central nervous system tumors (2003) Cancer Chemother Pharmacol, 52, pp. 435-441
Nicholson, H. S., Krailo, M., Ames, M. M., Phase i study of temozolomide in children and adolescents with recurrent solid tumors: A report from the Childrens Cancer Group (1998) J Clin Oncol, 16, pp. 3037-3043
Estlin, E. J., Lashford, L., Ablett, S., Phase i study of temozolomide in paediatric patients with advanced cancer (1998) Br J Cancer, 78 (5), pp. 652-661. , United Kingdom Childrens Cancer Study Group
Stevens, M. F., Hickman, J. A., Langdon, S. P., Antitumor activity and pharmacokinetics in mice of 8-carbamoyl-3-methyl- imidazo [5 i-d] -l235-tetrazin-4 (3h) -one (ccrg 81045
Newlands, E. S., Stevens, M. F., Wedge, S. R., Temozolomide: A review of its discovery chemical properties pre-clinical development and clinical trials (1997) Cancer Treat Rev, 23 (1), pp. 35-61
Palmer, S. L., Goloubeva, O., Reddick, W. E., Patterns of intellectual development among survivors of pediatric medulloblastoma: A longitudinal analysis (2001) J Clin Oncol, 19, pp. 2302-2308
Dunkel, I. J., Gardner, S. L., Garvin Jr., J. H., High-dose carboplatin thiotepa and etoposide with autologous stem cell rescue for patients with previously irradiated recurrent medulloblastoma (2010) Neuro Oncol, 12 (3), pp. 297-303
Finlay, J. L., Goldman, S., Wong, M. C., Pilot study of high-dose thiotepa and etoposide with autologous bone marrow rescue in children and young adults with recurrent CNS tumors (1996) J Clin Oncol, 14, pp. 2495-2503. , The Childrens Cancer Group
Bobola, M. S., Tseng, S. H., Blank, A., Role of O6-methylguanine-DNA methyltransferase in resistance of human brain tumor cell lines to the clinically relevant methylating agents temozolomide and streptozotocin (1996) Clin Cancer Res, 2 (4), pp. 735-741
Quinn, J. A., Jiang, S. X., Reardon, D. A., Phase II trial of temozolomide (TMZ) plus irinotecan (CPT-11) in adults with newly diagnosed glioblastoma multiforme before radiotherapy (2009) J Neurooncol, 95 (3), pp. 393-400
Sasine, J. P., Savaraj, N., Feun, L. G., Topoisomerase i inhibitors in the treatment of primary CNS malignancies: An update on recent trends (2010) Anticancer Agents Med Chem, 10 (9), pp. 683-696
Lo, H. W., Cao, X., Zhu, H., Constitutively activated stat3 frequently coexpresses with epidermal growth factor receptor in high-grade gliomas and targeting stat3 sensitizes them to iressa and alkylators (2008) Clin Cancer Res, 14 (19), pp. 6042-6054
Temozolomide is an active agent in children with recurrent medulloblastoma/primitive neuroectodermal tumor: An Italian multi-institutional phase II trial
Temozolomide is an active agent in children with recurrent medulloblastoma/primitive neuroectodermal tumor: An Italian multi-institutional phase II trial
Temozolomide is an active agent in children with recurrent medulloblastoma/primitive neuroectodermal tumor: An Italian multi-institutional phase II trial