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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT00180947

Collaborator

(none)

210

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhabdomyosarcomas Neoplasms, Connective and Soft Tissue Ewing Tumor Osteosarcomas Neuroblastomas Medulloblastomas	Drug: Vinorelbine, cyclofosfamide	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse []

Secondary Outcome Measures

To evaluate the hematologic tolerance of this association []
To evaluate the pharmacokinetics of injectable Vinorelbine []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 25 Years

Sexes Eligible for Study:

All

Accepts 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