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

September 7, 2006 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Odile OBERLIN, MD
  • Phone Number: 33 1 42 11 41 74
  • Email: oberlin@igr.fr

Study Contact Backup

  • Name: Annie REY
  • Phone Number: 01 42 11 41 37
  • Email: rey@igr.fr

Study Locations

  • France
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave-Roussy
        • Contact:
          • Odile OBERLIN, MD
          • Phone Number: 33 1 42 11 41 74
          • Email: oberlin@igr.fr
        • Contact:
          • Annie REY
          • Phone Number: 33 1 42 11 41 37
          • Email: rey@igr.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
To evaluate the hematologic tolerance of this association
To evaluate the pharmacokinetics of injectable Vinorelbine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Odile OBERLIN, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAVE-CYCLO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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