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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.


Phase 2
4 Years
21 Years
Open (Enrolling)
Both
Solid Tumors

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-tumour efficacy

Outcome Time Frame:

3 YEARS

Safety Issue:

Yes

Principal Investigator

BERNARD BELAIGUES

Investigator Role:

Study Director

Investigator Affiliation:

Assistance Publique hôpitaux de Marseille

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2010-12

NCT ID:

NCT01285817

Start Date:

November 2010

Completion Date:

May 2014

Related Keywords:

  • Solid Tumors
  • Neoplasms

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