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

Neoplasms, Connective and Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180947
• Other study ID #: NAVE-CYCLO
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 7, 2006
• Start date: June 2003

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Odile OBERLIN, MD
• Phone: 33 1 42 11 41 74
• Email: oberlin[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 25 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ewing Tumor
• Medulloblastoma
• Medulloblastomas
• Neoplasms, Connective and Soft Tissue
• Neuroblastoma
• Neuroblastomas
• Osteosarcoma
• Osteosarcomas
• Rhabdomyosarcoma
• Rhabdomyosarcomas

Intervention

Drug:
• Vinorelbine, cyclofosfamide

Locations

Country	Name	City	State
France	Institut Gustave-Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
Secondary	To evaluate the hematologic tolerance of this association
Secondary	To evaluate the pharmacokinetics of injectable Vinorelbine