Status:
COMPLETED
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Refractory Tumors
Malignant Tumors
Eligibility:
All Genders
6-21 years
Phase:
PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00412503
Last Update
August 7 2009
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, Ille de France, France, 94805