Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.