Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse

Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.

Inclusion Criteria:

• Age > 12 months and < 25 years

• Measurable disease

• Score of Lansky > 30 or World Health Organization (WHO) score < 2

• Life expectancy > 2 months

• Satisfactory hematologic conditions:

  • Polynuclear neutrophiles > 1 X 10^9/l.
  • Platelets > 100 X 10^9/l or > 50 X 10^9 in the event of medullary invasion.

• Creatinine < 1.5 of normal for age or clearance > 70 ml/min/1.73 m2

• Normal hepatic function:

  • Bilirubin < 3 N
  • ASAT and ALAT < 2,5 N).

• Absence of toxicity of bodies (Rank > 2 according to coding National Cancer Institute-Common Toxicity Criteria [NCI-CTC] version 2.0)

• Absence of antecedent of hematuric cystitis to repetition

• Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects

Exclusion Criteria:

• Does not satisfy the criteria of eligibility