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)

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Completed

Phase 2

Conditions

Survival Without Progression

Treatments

Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,

Study type

Interventional

Funder types

Other

Identifiers

NCT01285817

2010-021792-81 (EudraCT Number)

2010-12

Details and patient eligibility

About

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).

Full description

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)

Enrollment

79 patients

Sex

All

Ages

4 to 21 years old

Volunteers

No Healthy Volunteers

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