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Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

This study has been completed.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: December 15, 2006
Last updated: August 6, 2009
Last verified: August 2009
Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

Condition Intervention Phase
Refractory Tumors Malignant Tumors Drug: Topotecan, Temozolomide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • - To determine MTD and DLT of each drug

Secondary Outcome Measures:
  • To assess safety profile
  • To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
  • To assess the efficacy of the association


Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • histologically documented malignant tumor
  • refractory or relapsing after conventional treatments and for which there is no curative treatment available
  • life expectancy > 8 weeks
  • no significant co-morbidity (NCI-CTC < 2)
  • No organ toxicity
  • no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy

Exclusion Criteria:

  • Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds
  • Hypersensibility to Dacarbazine (DTIC)
  • Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase
  Contacts and Locations
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Please refer to this study by its identifier: NCT00412503

Institut Gustave Roussy
Villejuif, Ille de France, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Herve Rubie, MD CHU Toulouse
  More Information Identifier: NCT00412503     History of Changes
Other Study ID Numbers: CSET 1197
Study First Received: December 15, 2006
Last Updated: August 6, 2009

Additional relevant MeSH terms:
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on August 16, 2017