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

Phase 2

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

• Registration Number: NCT00180947
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

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Exclusion Criteria

• Does not satisfy the criteria of eligibility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse

Secondary Outcome Measures

Name	Time	Method
To evaluate the hematologic tolerance of this association
To evaluate the pharmacokinetics of injectable Vinorelbine

Trial Locations

Locations (1)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France