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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180947
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006

September 13, 2005
September 7, 2006
June 2003
Not Provided
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
To determine the antitumor activity of Vinorelbine + oral Cyclofosfamide association in the refractory tumours or in relapse
Complete list of historical versions of study NCT00180947 on ClinicalTrials.gov Archive Site
  • To evaluate the hematologic tolerance of this association
  • To evaluate the pharmacokinetics of injectable Vinorelbine
To evaluate the hematologic tolerance of this association To evaluate the pharmacokinetic one of injectable Vinorelbine
Not Provided
Not Provided
 
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rhabdomyosarcomas
  • Neoplasms, Connective and Soft Tissue
  • Ewing Tumor
  • Osteosarcomas
  • Neuroblastomas
  • Medulloblastomas
Drug: Vinorelbine, cyclofosfamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
Not Provided
Not Provided

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
Both
12 Months to 25 Years
No
Contact: Odile OBERLIN, MD 33 1 42 11 41 74 oberlin@igr.fr
Contact: Annie REY 01 42 11 41 37 rey@igr.fr
France
 
NCT00180947
NAVE-CYCLO
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: Odile OBERLIN, MD Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP