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Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Summary
The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.
Official title: Phase 2 Single- Arm Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Neuroblastoma and Other Paediatric Solid Tumours
Key Details
Gender
All
Age Range
6 Months - 20 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2009-06
Completion Date
2015-08
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
Temozolomide/Hycamtin (Topotecan)
Temozolomide: bottles containing 5 capsules of 5, 20, 100 and 250 mg Hycamtin (Topotecan): a lyophilisate for infusion in vials containing 4 mg Patients receive during 5 days (Day 1 to Day 5): Temozolomide 150 mg/m2/day per os, dose will be adjusted to the closest 5 mg, followed one hour later by Hycamtin(Topotecan) 0.75 mg/m2/day as an intravenous infusion over 30 minutes
Locations (1)
Institut Gustave Roussy
Villejuif, France