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

NCT ID: NCT00180947

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Soft parts tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Vinorelbine, cyclofosfamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Odile OBERLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Odile OBERLIN, MD

Role: CONTACT

Phone: 33 1 42 11 41 74

Email: [email protected]

Annie REY

Role: CONTACT

Phone: 01 42 11 41 37

Email: [email protected]

Facility Contacts

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Odile OBERLIN, MD

Role: primary

Annie REY

Role: backup

Other Identifiers

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NAVE-CYCLO

Identifier Type: -

Identifier Source: org_study_id