NCT00412503

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Refractory Tumors
• Malignant Tumors

Interventions

Type	Name	Description
DRUG	Topotecan, Temozolomide

Timeline

• First posted: 2006-12-18
• Last updated: 2009-08-07

Locations

1 site across 1 country: France