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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412503
First Posted: December 18, 2006
Last Update Posted: August 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412503


Locations
France
Institut Gustave Roussy
Villejuif, Ille de France, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Herve Rubie, MD CHU Toulouse
  More Information

ClinicalTrials.gov Identifier: NCT00412503     History of Changes
Other Study ID Numbers: CSET 1197
First Submitted: December 15, 2006
First Posted: December 18, 2006
Last Update Posted: August 7, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Neoplasms
Temozolomide
Dacarbazine
Topotecan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors