Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Phase 1
6 Months
21 Years
6 Months
21 Years
Not Enrolling
Both
Refractory Tumors, Malignant Tumors
Both
Refractory Tumors, Malignant Tumors
Trial Information
Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
- To determine MTD and DLT of each drug
Principal Investigator
Herve Rubie, MD
Investigator Role:
Study Chair
Investigator Affiliation:
CHU Toulouse
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CSET 1197
NCT ID:
NCT00412503
Start Date:
Completion Date:
Related Keywords:
- Refractory Tumors
- Malignant Tumors
- Neoplasms
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