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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 Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180947
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

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 Intervention Phase
Rhabdomyosarcomas
Neoplasms, Connective and Soft Tissue
Ewing Tumor
Osteosarcomas
Neuroblastomas
Medulloblastomas
 Drug: Vinorelbine, cyclofosfamide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

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

Estimated Enrollment: 210
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   12 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180947

Contacts
Contact: Odile OBERLIN, MD 33 1 42 11 41 74 oberlin@igr.fr
Contact: Annie REY 01 42 11 41 37 rey@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94800
Contact: Odile OBERLIN, MD     33 1 42 11 41 74     oberlin@igr.fr    
Contact: Annie REY     33 1 42 11 41 37     rey@igr.fr    
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Odile OBERLIN, MD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180947     History of Changes
Other Study ID Numbers: NAVE-CYCLO
Study First Received: September 13, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Soft parts tissue

Additional relevant MeSH terms:
Neoplasms
Medulloblastoma
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013