RhabdomyosarcomasPhase 2NCT00180947
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
A Phase 2 study testing Vinorelbine, cyclofosfamide in people with Rhabdomyosarcomas and Neoplasms, Connective and Soft Tissue, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 25 years
- Conditions the study is for
- Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor
- What is being tested?
- Vinorelbine, cyclofosfamide
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- Does not satisfy the criteria of eligibility
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Gustave-Roussy
Villejuif, 94800
Odile OBERLIN, MD, 33 1 42 11 41 74, oberlin@igr.fr
Annie REY, 33 1 42 11 41 37, rey@igr.fr
About this study
Official title: 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.
- Conditions
- Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor, Osteosarcomas, Neuroblastomas, Medulloblastomas
- Being tested
- Vinorelbine, cyclofosfamide
- Keywords
- Soft parts tissue
- Medical subject headings
- Rhabdomyosarcoma, Neoplasms, Connective and Soft Tissue, Sarcoma, Ewing, Osteosarcoma, Neuroblastoma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine, cyclofosfamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomasStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Odile OBERLIN, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180947
- Sponsor's protocol ID
- NAVE-CYCLO
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse
- ClinicalTrials.gov ID
- NCT00180947
- Acronym / sponsor ID
- NAVE-CYCLO
- Conditions
- Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor, Osteosarcomas, Neuroblastomas, Medulloblastomas
- Keywords
- Soft parts tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jun 2003
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (1 listed)
- Does not satisfy the criteria of eligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinorelbine, cyclofosfamide | Drug | – |
Primary outcome
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
2 secondary outcomes
To evaluate the hematologic tolerance of this association
To evaluate the pharmacokinetics of injectable Vinorelbine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile OBERLIN, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine, cyclofosfamide in people with Rhabdomyosarcomas and Neoplasms, Connective and Soft Tissue, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odile OBERLIN, MD (33 1 42 11 41 74, oberlin@igr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006.