Original Article

You have full text access to this OnlineOpen article

A phase II study of topotecan with vincristine and doxorubicin in children with recurrent/refractory neuroblastoma

  1. Alberto Garaventa M.D.1,†,*,
  2. Roberto Luksch M.D.2,
  3. Simona Biasotti M.D.1,
  4. Gianluca Severi M.D.3,
  5. Maria Rosa Pizzitola M.D.1,
  6. Elisabetta Viscardi M.D.4,
  7. Arcangelo Prete M.D.5,
  8. Stefano Mastrangelo M.D.6,
  9. Marta Podda M.D.2,
  10. Riccardo Haupt M.D.7,
  11. Bruno De Bernardi M.D.1

Article first published online: 16 OCT 2003

DOI: 10.1002/cncr.11797

Issue

Cancer

Cancer

Volume 98, Issue 11, pages 2488–2494, 1 December 2003

Additional Information

How to Cite

Garaventa, A., Luksch, R., Biasotti, S., Severi, G., Pizzitola, M. R., Viscardi, E., Prete, A., Mastrangelo, S., Podda, M., Haupt, R. and De Bernardi, B. (2003), A phase II study of topotecan with vincristine and doxorubicin in children with recurrent/refractory neuroblastoma. Cancer, 98: 2488–2494. doi: 10.1002/cncr.11797

Author Information

  1. 1

    Department of Pediatric Hematology/Oncology, Giannina Gaslini Children's Hospital, Genoa, Italy

  2. 2

    Operative Unit of Pediatrics, Istituto Nazionale Tumori, Milan, Italy

  3. 3

    Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy

  4. 4

    Department of Pediatrics, University of Padua, Padua, Italy

  5. 5

    Department of Pediatrics, University of Bologna, Bologna, Italy

  6. 6

    Department of Pediatrics, Policlinico Gemelli, Rome, Italy

  7. 7

    Section of Epidemiology and Biostatistics, Giannina Gaslini Children's Hospital, Genoa, Italy

  1. †

    Fax: (011) 39-0103777133

*Department of Pediatric Hematology/Oncology, Giannina Gaslini Children's Hospital, Genoa, Italy

Publication History

  1. Issue published online: 17 NOV 2003
  2. Article first published online: 16 OCT 2003
  3. Manuscript Accepted: 25 AUG 2003
  4. Manuscript Revised: 19 AUG 2003
  5. Manuscript Received: 11 JUN 2003

Funded by

  • Italian National Research Council, Project Consiglio Nazionale della Ricerca-Ministero dell'Istruzione, dell'Università e della Ricerca (CNR-MIUR)
  • Minister of Health-Special Programs Research “Finalizzata 2000” and “Finalizzata 2002”
  • Italian Neuroblastoma Association (Genoa, Italy)

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (85K)

REFERENCES

  • 1
    Ladenstein R, Philip T, Lasset C, et al. Multivariate analysis of risk factors in Stage 4 neuroblastoma patients over the age of one year treated with megatherapy and stem-cell transplantation: a report from the European Bone Marrow Transplantation Solid Tumor Registry. J Clin Oncol. 1998; 16: 953–965.
  • 2
    Matthay KK, Villablanca JG, Seeger RC, et al. Treatment of high-risk neuroblastoma with intensive chemotherapy, radiotherapy, autologous bone marrow transplantation, and 13-cis-retinoic acid. Children's Cancer Group. N Engl J Med. 1999; 341: 1165–1173.
  • 3
    Kollmannsberger C, Mross K, Jakob A, et al. Topotecan a novel topoisomerase I inhibitor: pharmacology and clinical experience. Oncology. 1999; 56: 1–12.
  • 4
    Vassal G, Pondarré C, Cappelli C, et al. DNA-topoisomerase I, a new target for the treatment of neuroblastoma. Eur J Cancer. 1997; 33: 2011–2015.
  • 5
    Houghton PJ, Cheshire PJ, Myers L, et al. Evaluation of 9-dimethylaminomethyl-10-hydroxycamptothecin against xenografts derived from adult and childhood solid tumors. Cancer Chemother Pharmacol. 1992; 31: 229–239.
  • 6
    Zamboni WC, Stewart CF, Thompson J, et al. Relationship between topotecan systemic exposure and tumor response in human neuroblastoma xenografts. J Natl Cancer Inst. 1998; 90: 505–511.
  • 7
    Rewinsky K, Verweij J. Review of Phase I clinical studies with topotecan. Semin Oncol. 1998; 24: 3–20.
  • 8
    McGuire P, William P, Blessing JA, et al. Topotecan has substantial antitumor activity as first-line salvage therapy in platinum-sensitive epithelial ovarian carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2000; 18: 1062–1067.
  • 9
    Tubergen DG, Stewart CF, Pratt CB, et al. Phase I trial and pharmacokinetic (PK) and pharmacodynamics (PD) study of topotecan using a five-day course in children with refractory solid tumors: a Pediatric Oncology Group Study. J Pediatr Hematol Oncol. 1996; 18: 352–361.
  • 10
    Saylors RL III, Stine KC, Sullivan J, et al. Cyclophosphamide plus topotecan in children with recurrent or refractory solid tumors: a Pediatric Oncology Group Phase II study. J Clin Oncol. 2001; 19: 3463–3469.
  • 11
    Rowinsky EK, Kaufmann SH. Topotecan in combination chemotherapy. Semin Oncol. 1997; 24(6 Suppl 20 ): S20-11–S20-26.
  • 12
    Kim R, Hirabayashi N, Nishiyama M, Jinushi K, Toge T, Okada K. Experimental studies on biochemical modulation targeting topoisomerase I and II in human tumor xenografts in nude mice. Int J Cancer. 1992; 50: 760–766.
    Direct Link:
  • 13
    Thompson J, George EO, Poquette CA, et al. Synergy of topotecan in combination with vincristine for treatment of pediatric solid tumor xenografts. Clin Cancer Res. 1999; 5: 3617–3631.
  • 14
    Helson L, Groshen S, Castello MA, et al. Constant infusion vincristine-Adriamycin in pediatric cancer [abstract]. XVII Meeting of the International Society of Pediatric Oncology, Venice, Italy, September 30–October 4, 1985.
  • 15
    National Cancer Institute. Guidelines for reporting of adverse drug reactions. Bethesda: National Cancer Institute, 1998.
  • 16
    Brodeur GM, Pritchard J, Berthold F, et al. Revisions of the International Criteria for Neuroblastoma Diagnosis, Staging, and Response to Treatment. J Clin Oncol. 1993; 11: 1466–1477.
  • 17
    Bryant J, Day R. Incorporating toxicity considerations into the design of two-stage Phase II clinical trials. Biometrics. 1995; 51: 1372–1383.
  • 18
    Kushner BH, Kramer K, Meyers PA, et al. Pilot study of topotecan and high-dose cyclophosphamide for resistant pediatric solid tumors. Med Pediatr Oncol. 2000; 35: 468–474.
    Direct Link:
  • 19
    Wells RJ, Reid JM, Ames MM, et al. Phase I trial of cisplatin and topotecan in children with recurrent solid tumors: Children's Cancer Group Study 0942. J Pediatr Hematol Oncol. 2002; 24: 89–93.
  • 20
    Athale UH, Stewart C, Kuttesch JF, et al. Phase I study of combination topotecan and carboplatin in pediatric solid tumors. J Clin Oncol. 2002; 20: 88–95.
  • 21
    Cheung MF, Chatterjee S, Berger NA. Schedule-dependent cytotoxicity of topotecan alone and in combination chemotherapy regimens. Oncol Res. 1994; 6: 269–279.
  • 22
    Jonsson E, Fridborg H, Nygren P. Synergistic interactions of combination of topotecan with standard drugs in primary cultures of human tumor cells from patients. Eur J Clin Pharmacol. 1998; 54: 509–514.
  • 23
    Murren JR, Anderson S, Fedele J, et al. Dose-escalation and pharmacodynamic study of topotecan in combination with cyclophosphamide in patients with refractory cancer. J Clin Oncol. 1997; 15: 148–157.
  • 24
    Seiden MV, Ng SW, Supko JG, et al. A Phase I clinical trial of sequentially administered doxorubicin and topotecan in refractory solid tumors. Clin Cancer Res. 2002; 8: 691–697.
  • 25
    Goldwasser F, Buthaud X, Gross M. Decreased topotecan platelet toxicity with successive topotecan treatment cycles in advanced ovarian cancer patients. Anticancer Drugs. 1999; 10: 263–265.
  • 26
    Frappaz D, Michon J, Hartmann O, et al. Etoposide and carboplatin in neuroblastoma: a French Society of Pediatric Oncology Phase II study. J Clin Oncol. 1992; 10: 1592–1601.
  • 27
    Meresse V, Vassal G, Michon J, et al. Combined continuous infusion etoposide with high-dose cyclophosphamide for refractory neuroblastoma: a Phase II study from the Société Française d'Oncologie Pédiatrique. J Clin Oncol. 1993; 11: 630–637.
  • 28
    Alvarado CS, Kretschmar C, Joshi VV, et al. Chemotherapy for patients with recurrent or refractory neuroblastoma: a POG Phase II study. J Pediatr Hematol Oncol. 1997; 19: 62–67.
  • 29
    Frappaz D, Bouffet E, Perel Y, et al. Phase II study of cisplatinum and carboplatinum (CACIS) combination in advanced stage neuroblastomas. Med Pediatr Oncol. 1998; 30: 9–14.
    Direct Link:
  • 30
    McWilliams NB, Hayes FA, Green AA, et al. Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995; 24: 176–180.
    Direct Link:
  • 31
    De Bernardi B, Nicolas B, Boni L, et al. Disseminated neuroblastoma in children older than one year at diagnosis. Comparable results with three consecutive high-dose protocols adopted by the Italian Cooperative Group for Neuroblastoma (ICGNB). J Clin Oncol. 2003; 21: 1592–1601.
  • 32
    Kretschmar C, Kletzel M, Murray K, et al. Up-front Phase II therapy with Taxol and topotecan in untreated children with disseminated neuroblastoma. A Pediatric Oncology Group study (SIOP XXVII Meeting) [abstract]. Med Pediatr Oncol. 1995; 25: 243.
  • 33
    Pearson AD, Pinkerton CR, Levis IJ. European Neuroblastoma Group Fifth Study (ENSG 5). A randomised study of dose intensity in Stage 4 neuroblastoma over the age of one. In: EvansAE, BiedlerJL, BrodeurGM, D'AngioGJ, NakagawaraA, editors. Progress in clinical and biological research—advances in neuroblastoma research. New York: Wiley-Liss, 1994: 385–394.
View Full Article (HTML) Get PDF (85K)