A 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)

Inclusion criteria

• Patients must have a histologically or cytologically confirmed malignant solid tumour.
• Progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion.
• Disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists.
• Age: ≥4 to 21 years of age at study entry
• Life expectancy: at least 8 weeks
• ECOG Performance status ≤ 1 or Lansky-Play Scale ≥ 70%
• Written informed consent of parent/guardian and patient assent
• Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions).
• Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study
• Able to comply with scheduled follow-up and with management of toxicity
• All patients with reproductive potential must practice an effective method of birth control while on study.
• Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment.
• Capable of swallowing oral medication

Exclusion criteria

• Pregnant and breast feeding women.
• Uncontrolled intercurrent illness or active infection
• Inability to swallow oral medication.
• Patients on anticonvulsants will be allowed on study