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

Primary Purpose

Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Vinorelbine, cyclofosfamide
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhabdomyosarcomas focused on measuring Soft parts tissue

Eligibility Criteria

12 Months - 25 Years (Child, Adult)All SexesDoes not accept 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 Exclusion Criteria: Does not satisfy the criteria of eligibility

Sites / Locations

  • Institut Gustave-RoussyRecruiting

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00180947
Brief Title
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
Official Title
Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor, Osteosarcomas, Neuroblastomas, Medulloblastomas
Keywords
Soft parts tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vinorelbine, cyclofosfamide
Primary Outcome Measure Information:
Title
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
Secondary Outcome Measure Information:
Title
To evaluate the hematologic tolerance of this association
Title
To evaluate the pharmacokinetics of injectable Vinorelbine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odile OBERLIN, MD
Phone
33 1 42 11 41 74
Email
oberlin@igr.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Annie REY
Phone
01 42 11 41 37
Email
rey@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile OBERLIN, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odile OBERLIN, MD
Phone
33 1 42 11 41 74
Email
oberlin@igr.fr
First Name & Middle Initial & Last Name & Degree
Annie REY
Phone
33 1 42 11 41 37
Email
rey@igr.fr

12. IPD Sharing Statement

Learn more about this trial

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

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