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Phase I study of fotemustine in pediatric patients with refractory brain tumors

  1. Darren R. Hargrave M.D.1,2,
  2. Eric Bouffet M.D.1,
  3. Janet Gammon R.N.1,
  4. Nauman Tariq M.Sc.2,
  5. Ron M. Grant M.D.3,
  6. Sylvain Baruchel M.D.1,2,†,*

Article first published online: 5 SEP 2002

DOI: 10.1002/cncr.10814

Issue

Cancer

Cancer

Volume 95, Issue 6, pages 1294–1301, 15 September 2002

Additional Information

How to Cite

Hargrave, D. R., Bouffet, E., Gammon, J., Tariq, N., Grant, R. M. and Baruchel, S. (2002), Phase I study of fotemustine in pediatric patients with refractory brain tumors. Cancer, 95: 1294–1301. doi: 10.1002/cncr.10814

Author Information

  1. 1

    New Agents and Innovative Therapy Program, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

  2. 2

    Pediatric Brain Tumor Program, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

  3. 3

    Division of Haematology/Oncology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

  1. †

    Fax: 416-813-8024

*New Agents and Innovative Therapy Program, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada

Publication History

  1. Issue published online: 5 SEP 2002
  2. Article first published online: 5 SEP 2002
  3. Manuscript Accepted: 6 MAY 2002
  4. Manuscript Revised: 17 MAR 2002
  5. Manuscript Received: 16 JAN 2002

Funded by

  • Servier Research International, France

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Keywords:

  • fotemustine;
  • nitrosourea;
  • Phase I;
  • pediatric;
  • brain tumors

Abstract

BACKGROUND

Fotemustine is a nitrosourea with theoretic and preclinical advantages over the original analogs, carmustine and lomustine, in the treatment of brain tumors. This is the first pediatric Phase I study of fotemustine.

METHODS

Patients younger than 21 with recurrent/resistant brain tumors were enrolled in a conventional Phase I study. Fotemustine was administered intravenously every 3 weeks at increasing dose levels starting at 100 mg/m2. Toxicity and response data were monitored closely.

RESULTS

Fifteen evaluable patients entered the study and received a total of 45 courses of fotemustine (dose range, 100–175 mg/m2). Myelosuppression was observed, with the dose-limiting toxicity being Grade 4 neutropenia and thrombocytopenia. Toxicity was delayed and cumulative. The maximum tolerated dose was 150 mg/m2 every 3 weeks. There were three documented radiologic responses (20% of patients) comprising one partial response and two minor responses in patients with a sarcoma, medulloblastoma, and ependymoma, respectively.

CONCLUSIONS

Fotemustine administered at a dose of 150 mg/m2 every 3 weeks is well tolerated in children and has antitumor activity in several brain tumors. This is the first dedicated Phase I study of a single agent nitrosourea in a pediatric population. More comparative studies should be undertaken to define the optimum nitrosourea analog for use in children with brain tumors. Cancer 2002;95:1294–301. © 2002 American Cancer Society.

DOI 10.1002/cncr.10814

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