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. (SFCE METRO 01)
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).
Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Anti-tumour efficacy [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]
- Safety AND Pharmacodynamic Study [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: traetment||Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,|
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)
|Contact: ARNAUD VERSCHUUR||04 91 38 84 email@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: arnaud verschuur firstname.lastname@example.org|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|