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

This study has been completed.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00412503
First received: December 15, 2006
Last updated: August 6, 2009
Last verified: August 2009
  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
Endpoint Classification: Safety/Efficacy Study
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

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00412503     History of Changes
Other Study ID Numbers: CSET 1197
Study First Received: December 15, 2006
Last Updated: August 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 20, 2014