Status:
UNKNOWN
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Rhabdomyosarcomas
Neoplasms, Connective and Soft Tissue
Eligibility:
All Genders
12-25 years
Phase:
PHASE2
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 ti...
Eligibility Criteria
Inclusion
- 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
- Does not satisfy the criteria of eligibility
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00180947
Start Date
June 1 2003
Last Update
September 8 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Gustave-Roussy
Villejuif, France, 94800