Clinical trial NCT00978471 - References

Osteosarcoma — Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma

Citation(s)

•   Bacci G, Briccoli A, Longhi A, Ferrari S, Mercuri M, Faggioli F, Versari M, Picci P
  Treatment and outcome of recurrent osteosarcoma: experience at Rizzoli in 235 patients initially treated with neoadjuvant chemotherapy. Acta Oncol. 2005;44(7):748-55.
•   Beron G, Euler A, winkley K
  pulmonary metastase from osteogenic sarcoma: Complete resection and effective chemotherapy contributing to improved prognosis.Eur Paediatr Haematol Oncol 1985; 2:77-85
•   Bertolini F, Mancuso P, Shaked Y, Kerbel RS
  Molecular and cellular biomarkers for angiogenesis in clinical oncology. Drug Discov Today. 2007 Oct;12(19-20):806-12. Epub 2007 Sep 27. Review.
•   Bielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jürgens H, Winkler K
  Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 2002 Feb 1;20(3):776-90.
•   Claude L, Rousmans S, Carrie C, Breteau N, Dijoud F, Gentet JC, Giammarile F, Jouve JL, Kind M, Marec-Bérard P, Mascard E, Bataillard A, Philip T; Institut National du Cancer; Fédéation nationale des centres de lutte contre le cancer (FNCLCC); Standards, Options et Recommendations; Ligue nationale contre le cancer; SFCE; Fédéation hospitalière de France; FNCHRU; Fédéation française de cancérologie
  [Standards and Options for the use of radiation therapy in the management of patients with osteosarcoma. Update 2004]. Bull Cancer. 2005 Oct;92(10):891-906. Review. French.
•   Cores EP, Holland JF, Wang JJ, Sinks LF
  Doxorubicin in disseminated osteosarcoma. JAMA. 1972 Sep 4;221(10):1132-8.
•   Crompton BD, Goldsby RE, Weinberg VK, Feren R, O'Donnell RJ, Ablin AR
  Survival after recurrence of osteosarcoma: a 20-year experience at a single institution. Pediatr Blood Cancer. 2006 Sep;47(3):255-9.
•   Desandes E, Lacour B, Sommelet D, Buemi A, Danzon A, Delafosse P, Grosclaude P, Mace-Lesech J, Raverdy-Bourdon N, Tretarre B, Velten M, Brugieres L
  Cancer incidence among adolescents in France. Pediatr Blood Cancer. 2004 Dec;43(7):742-8.
•   Entz-Werlé N, Marcellin L, Gaub MP, Guerin E, Schneider A, Berard-Marec P, Kalifa C, Brugiere L, Pacquement H, Schmitt C, Tabone MD, Jeanne-Pasquier C, Terrier P, Dijoud F, Oudet P, Lutz P, Babin-Boilletot A
  Prognostic significance of allelic imbalance at the c-kit gene locus and c-kit overexpression by immunohistochemistry in pediatric osteosarcomas. J Clin Oncol. 2005 Apr 1;23(10):2248-55.
•   Entz-Werle N, Schneider A, Kalifa C, Voegeli AC, Tabone MD, Marec-Berard P, Marcellin L, Pacquement H, Terrier P, Boutard P, Meyer N, Gaub MP, Lutz P, Babin A, Oudet P
  Genetic alterations in primary osteosarcoma from 54 children and adolescents by targeted allelotyping. Br J Cancer. 2003 Jun 16;88(12):1925-31.
•   Entz-Werlé N, Stoetzel C, Berard-Marec P, Kalifa C, Brugiere L, Pacquement H, Schmitt C, Tabone MD, Gentet JC, Quillet R, Oudet P, Lutz P, Babin-Boilletot A, Gaub MP, Perrin-Schmitt F
  Frequent genomic abnormalities at TWIST in human pediatric osteosarcomas. Int J Cancer. 2005 Nov 10;117(3):349-55.
•   Ferrari S, Briccoli A, Mercuri M, Bertoni F, Cesari M, Longhi A, Bacci G
  Late relapse in osteosarcoma. J Pediatr Hematol Oncol. 2006 Jul;28(7):418-22.
•   Ferrari S, Briccoli A, Mercuri M, Bertoni F, Picci P, Tienghi A, Del Prever AB, Fagioli F, Comandone A, Bacci G
  Postrelapse survival in osteosarcoma of the extremities: prognostic factors for long-term survival. J Clin Oncol. 2003 Feb 15;21(4):710-5.
•   Finlay JL, Goldman S, Wong MC, Cairo M, Garvin J, August C, Cohen BH, Stanley P, Zimmerman RA, Bostrom B, Geyer JR, Harris RE, Sanders J, Yates AJ, Boyett JM, Packer RJ
  Pilot study of high-dose thiotepa and etoposide with autologous bone marrow rescue in children and young adults with recurrent CNS tumors. The Children's Cancer Group. J Clin Oncol. 1996 Sep;14(9):2495-503.
•   Franzius C, Schuck A, Bielack SS
  High-dose samarium-153 ethylene diamine tetramethylene phosphonate: low toxicity of skeletal irradiation in patients with osteosarcoma and bone metastases. J Clin Oncol. 2002 Apr 1;20(7):1953-4.
•   Freedman LS
  Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9.
•   Gasparini M, Rouesse J, van Oosterom A, Wagener T, Somers R, Russel JA, Voûte PA, Bramwell V, Thomas D, Sylvester R, et al
  Phase II study of cisplatin in advanced osteogenic sarcoma. European Organization for Research on Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Cancer Treat Rep. 1985 Feb;69(2):211-3.
•   Gelderblom H, Sydes MR, Morgan RC, Hogendoorn PC, Lewis IJ, Nooij MA, Taminiau AH, and whelan J
  Survival after reccurent osteosarcoma: Data from three European Osteosarcoma Intergroup (EOI) randomized controlled trials.J Clin Oncol26.20-5-2008
•   Hagen B, Walseth F, Walstad RA, Iversen T, Nilsen OG
  Single and repeated dose pharmacokinetics of thio-TEPA in patients treated for ovarian carcinoma. Cancer Chemother Pharmacol. 1987;19(2):143-8.
•   Harris MB, Gieser P, Goorin AM, Ayala A, Shochat SJ, Ferguson WS, Holbrook T, Link MP
  Treatment of metastatic osteosarcoma at diagnosis: a Pediatric Oncology Group Study. J Clin Oncol. 1998 Nov;16(11):3641-8.
•   Hart RD, Perloff M, Holland JF
  One-day VATH (vinblastine, Adriamycin, thiotepa, and Halotestin) therapy for advanced breast cancer refractory to chemotherapy. Cancer. 1981 Oct 1;48(7):1522-7.
•   Heideman RL, Cole DE, Balis F, Sato J, Reaman GH, Packer RJ, Singher LJ, Ettinger LJ, Gillespie A, Sam J, et al
  Phase I and pharmacokinetic evaluation of thiotepa in the cerebrospinal fluid and plasma of pediatric patients: evidence for dose-dependent plasma clearance of thiotepa. Cancer Res. 1989 Feb 1;49(3):736-41.
•   Huth JF, Eilber FR
  Patterns of recurrence after resection of osteosarcoma of the extremity. Strategies for treatment of metastases. Arch Surg. 1989 Jan;124(1):122-6.
•   Jaffe N, Paed D, Farber S, Traggis D, Geiser C, Kim BS, Das L, Frauenberger G, Djerassi I, Cassady JR
  Favorable response of metastatic osteogenic sarcoma to pulse high-dose methotrexate with citrovorum rescue and radiation therapy. Cancer. 1973 Jun;31(6):1367-73.
•   Jeffree GM, Price CH, Sissons HA
  The metastatic patterns of osteosarcoma. Br J Cancer. 1975 Jul;32(1):87-107.
•   Kalifa C, Hartmann O, Demeocq F, Vassal G, Couanet D, Terrier-Lacombe MJ, Valteau D, Brugieres L, Lemerle J
  High-dose busulfan and thiotepa with autologous bone marrow transplantation in childhood malignant brain tumors: a phase II study. Bone Marrow Transplant. 1992 Apr;9(4):227-33.
•   Kaplan EL MP
  Nonparametric estimation from incomplete observations.J Am Stat Assoc 1958
•   Kempf-Bielack B, Bielack SS, Jürgens H, Branscheid D, Berdel WE, Exner GU, Göbel U, Helmke K, Jundt G, Kabisch H, Kevric M, Klingebiel T, Kotz R, Maas R, Schwarz R, Semik M, Treuner J, Zoubek A, Winkler K
  Osteosarcoma relapse after combined modality therapy: an analysis of unselected patients in the Cooperative Osteosarcoma Study Group (COSS). J Clin Oncol. 2005 Jan 20;23(3):559-68.
•   Kletzel M, Kearns GL, Wells TG, Thompson HC Jr
  Pharmacokinetics of high dose thiotepa in children undergoing autologous bone marrow transplantation. Bone Marrow Transplant. 1992 Aug;10(2):171-5.
•   Lazarus HM, Reed MD, Spitzer TR, Rabaa MS, Blumer JL
  High-dose i.v. thiotepa and cryopreserved autologous bone marrow transplantation for therapy of refractory cancer. Cancer Treat Rep. 1987 Jul-Aug;71(7-8):689-95.
•   Leary SE,Billups A, Watkins A, Wu J, Poe D, Neel MN, Rao BN and Daw NC
  Survival of pediatric patients after relapsed osteosarcoma:The St.Jude Children's Research Hospital experience.JOclin Oncol 26.20-5-2008
•   Lucidarme N, Valteau-Couanet D, Oberlin O, Couanet D, Kalifa C, Beaujean F, Lapierre V, Hartmann O
  Phase II study of high-dose thiotepa and hematopoietic stem cell transplantation in children with solid tumors. Bone Marrow Transplant. 1998 Sep;22(6):535-40.
•   Marti C, Kroner T, Remagen W, Berchtold W, Cserhati M, Varini M
  High-dose ifosfamide in advanced osteosarcoma. Cancer Treat Rep. 1985 Jan;69(1):115-7.
•   Mialou V, Philip T, Kalifa C, Perol D, Gentet JC, Marec-Berard P, Pacquement H, Chastagner P, Defaschelles AS, Hartmann O
  Metastatic osteosarcoma at diagnosis: prognostic factors and long-term outcome--the French pediatric experience. Cancer. 2005 Sep 1;104(5):1100-9.
•   Nardin A, Lefebvre ML, Labroquère K, Faure O, Abastado JP
  Liposomal muramyl tripeptide phosphatidylethanolamine: Targeting and activating macrophages for adjuvant treatment of osteosarcoma. Curr Cancer Drug Targets. 2006 Mar;6(2):123-33. Review.
•   Oliveira ID, Petrilli AS, Tavela MH, Zago MA, de Toledo SR
  TNF-alpha, TNF-beta, IL-6, IL-10, PECAM-1 and the MPO inflammatory gene polymorphisms in osteosarcoma. J Pediatr Hematol Oncol. 2007 May;29(5):293-7.
•   Rialland F
  Treatment and outcome of relapsed osteosarcoma:experience of the societe française des cancers de l'enfant.(in press). 2008. Ref type:in press
•   Rosen G, Caparros B, Huvos AG, Kosloff C, Nirenberg A, Cacavio A, Marcove RC, Lane JM, Mehta B, Urban C
  Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy. Cancer. 1982 Mar 15;49(6):1221-30.
•   Saeter G, Høie J, Stenwig AE, Johansson AK, Hannisdal E, Solheim OP
  Systemic relapse of patients with osteogenic sarcoma. Prognostic factors for long term survival. Cancer. 1995 Mar 1;75(5):1084-93.
•   Schemper M, Smith TL
  A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996 Aug;17(4):343-6.
•   Shi XB, Chen AM, Cai XH, Guo FJ, Liao GN, Ma D
  Establishment and characterization of cell sublines with high and low metastatic potential derived from human osteosarcoma. Chin Med J (Engl). 2005 Apr 20;118(8):687-90.
•   Souhami RL, Craft AW, Van der Eijken JW, Nooij M, Spooner D, Bramwell VH, Wierzbicki R, Malcolm AJ, Kirkpatrick A, Uscinska BM, Van Glabbeke M, Machin D
  Randomised trial of two regimens of chemotherapy in operable osteosarcoma: a study of the European Osteosarcoma Intergroup. Lancet. 1997 Sep 27;350(9082):911-7.
•   Sutow WW, Herson J, Perez C
  Survival after metastasis in osteosarcoma. Natl Cancer Inst Monogr. 1981 Apr;(56):227-31.
•   Tabone MD, Kalifa C, Rodary C, Raquin M, Valteau-Couanet D, Lemerle J
  Osteosarcoma recurrences in pediatric patients previously treated with intensive chemotherapy. J Clin Oncol. 1994 Dec;12(12):2614-20.
•   Weeden S, Grimer RJ, Cannon SR, Taminiau AH, Uscinska BM; European Osteosarcoma Intergroup
  The effect of local recurrence on survival in resected osteosarcoma. Eur J Cancer. 2001 Jan;37(1):39-46.
•   Widhe B, Widhe T
  Initial symptoms and clinical features in osteosarcoma and Ewing sarcoma. J Bone Joint Surg Am. 2000 May;82(5):667-74.

Efficacy and Tolerance Adjuvant High-Dose Thiotepa With Peripheral Stem Cell Rescue Associated With Conventional Chemotherapy in Children and Adults With Relapsed Osteosarcoma

Details for clinical trial NCT00978471