Survival Without Progression Clinical Trial
Official title:
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.
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response"). To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
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) ;