A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.
Multi-center, combination phase II study, open-label, non-comparative, non-randomized.
All progressive or recurrent solid tumours will be included in the Phase II study, provided
there are no curative options anymore.
Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anti-tumour efficacy
3 YEARS
Yes
BERNARD BELAIGUES
Study Director
Assistance Publique hôpitaux de Marseille
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2010-12
NCT01285817
November 2010
May 2014
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