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

NCT00180947 | Unknown Phase 2

• 1 other identifier: NAVE-CYCLO
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Soft parts tissue

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• To evaluate the hematologic tolerance of this association

• To evaluate the pharmacokinetics of injectable Vinorelbine

Interventions

Vinorelbine, cyclofosfamide DRUG

Eligibility Criteria

• Age: 12 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Does not satisfy the criteria of eligibility

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave-Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Rhabdomyosarcoma; Neoplasms, Connective and Soft Tissue; Sarcoma, Ewing; Osteosarcoma; Neuroblastoma; Medulloblastoma

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Glioma

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Odile OBERLIN, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odile OBERLIN, MD

CONTACT

33 1 42 11 41 74; oberlin@igr.fr

Annie REY

CONTACT

01 42 11 41 37; rey@igr.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Last Updated: September 8, 2006

Record last verified: 2006-09

Locations

FR (1)