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)
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|ClinicalTrials.gov Identifier: NCT01285817|
Recruitment Status : Unknown
Verified October 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : January 28, 2011
Last Update Posted : October 23, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumours.||Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,||Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||March 2016|
|Experimental: traetment||Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,|
- Anti-tumour efficacy [ Time Frame: 3 YEARS ]
- Safety AND Pharmacodynamic Study [ Time Frame: 3 YEARS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285817
|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|