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

Gustave Roussy

Status and phase: Unknown; Phase 2

Conditions: Neuroblastomas; Medulloblastomas; Rhabdomyosarcomas; Osteosarcomas; Neoplasms, Connective and Soft Tissue; Ewing Tumor

Treatments: Drug: Vinorelbine, cyclofosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00180947

NAVE-CYCLO

Details and patient eligibility

About

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.

Sex: All

Ages: 12 months to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)