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COMPLETED
NCT00918320
PHASE2

Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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

Interventions

DRUG

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