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Completed

NCT Number: NCT00412503

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

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.

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Key information

Conditions

Refractory Tumors Malignant Tumors Neoplasms

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Gustave Roussy

Villejuif, Ille de France, 94805, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan, Temozolomide

Drug

Primary outcomes

  1. - To determine MTD and DLT of each drug

Secondary outcomes

  1. To assess safety profile

  2. To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated

  3. To assess the efficacy of the association

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Important dates

First posted
Dec 18, 2006
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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