children and adolescents with relapsed or progressing solid tumours.
Conditions
Interventions
Trade Name: CELEBREX 100MG
Product Name: CELECOXIB
Product Code: CELEBREX
Pharmaceutical Form: Capsule*
INN or Proposed INN: Célécoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
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 and 6 months (3 months minimum) after the end of treatment. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment. Capable of swallowing oral medication. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 21 ans - Femme enceinte ou allaitante - Présentant une contre-indication à l’utilisation d’un des produits de l’étude. - Homme ou femme en âge de procréer sans contraception efficace durant l’étude et dans les 6 mois suivant l’arrêt du traitement (3 mois minimum) - Score de Lansky 2. - Espérance de vie 2 selon codification NCI-CTC v2.0, Annexe 17) - Infection active
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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”). ;Secondary Objective: To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles). ;Primary end point(s): - Anti-tumour efficacy : Progression-free survival after 2 cycles (4 months) and 12 months as well as response rate after two cycles, as assessed by conventional imaging (CT/MRI). | — |
Countries
France
Outcome results
None listed