Survival Without ProgressionPhase 2SFCE METRO 01NCT01285817
A Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing soliD Tumours.
A Phase 2 study testing celecoxib, Vinblastine, Cyclophosphamide , methotrexate , in people with Survival Without Progression, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response"). To define the safety profile of the combination. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Survival Without Progression
- What is being tested?
- celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2011to 9 Mar 2023
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have a histologically or cytologically confirmed malignant solid tumour.
- Progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion.
- Disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists.
- Age: ≥4 to 21 years of age at study entry
- Life expectancy: at least 8 weeks
- ECOG Performance status ≤ 1 or Lansky-Play Scale ≥ 70%
Show all 13Show fewer
- Written informed consent of parent/guardian and patient assent
- Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions).
- Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study
- Able to comply with scheduled follow-up and with management of toxicity
- All patients with reproductive potential must practice an effective method of birth control while on study.
- Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment.
- Capable of swallowing oral medication
Who cannot join
- Pregnant and breast feeding women.
- Uncontrolled intercurrent illness or active infection
- Inability to swallow oral medication.
- Patients on anticonvulsants will be allowed on study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").
To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
Read the detailed description
Multi-center, combination phase II study, open-label, non-comparative, non-randomized.
All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore.
Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
- Conditions
- Survival Without Progression
- Being tested
- celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,Drug
| Study group | Role | What they receive |
|---|---|---|
| traetment | Experimental | Not described Receives: Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate , |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumour efficacy
Measured: 3 YEARS
Secondary outcomes (1)
Safety AND Pharmacodynamic Study
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study start12 Jan 2011
- Primary completion11 Sep 2015
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Survival Without ProgressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285817
- Sponsor's protocol ID
- 2010-12
- Other IDs
- 2010-021792-81
- Acronym
- SFCE METRO 01
- Status last verified
- Oct 2015
- First submitted
- 6 Jan 2011
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Verschuur A, Heng-Maillard MA, Dory-Lautrec P, Truillet R, Jouve E, Chastagner P, Leblond P, Aerts I, Honore S, Entz-Werle N, Sirvent N, Gentet JC, Corradini N, Andre N. Metronomic Four-Drug Regimen Has Anti-tumor Activity in Pediatric Low-Grade Glioma; The Results of a Phase II Clinical Trial. Front Pharmacol. 2018 Sep 27;9:00950. doi: 10.3389/fphar.2018.00950. eCollection 2018.
PubMed 30319400Andre N, Abed S, Orbach D, Alla CA, Padovani L, Pasquier E, Gentet JC, Verschuur A. Pilot study of a pediatric metronomic 4-drug regimen. Oncotarget. 2011 Dec;2(12):960-5. doi: 10.18632/oncotarget.358.
PubMed 22156656
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.
- ClinicalTrials.gov ID
- NCT01285817
- Acronym / sponsor ID
- SFCE METRO 01 / 2010-12
- Conditions
- Survival Without Progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 12 Jan 2011 (actual)
- Primary completion
- 11 Sep 2015 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 28 Jan 2011 (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.
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").
To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
Detailed description
Multi-center, combination phase II study, open-label, non-comparative, non-randomized.
All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore.
Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traetment | Experimental | Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate , |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Patients must have a histologically or cytologically confirmed malignant solid tumour.
- Progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion.
- Disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists.
- Age: ≥4 to 21 years of age at study entry
- Life expectancy: at least 8 weeks
Key exclusion criteria (4 listed)
- Pregnant and breast feeding women.
- Uncontrolled intercurrent illness or active infection
- Inability to swallow oral medication.
- Patients on anticonvulsants will be allowed on study
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 |
|---|---|---|
| celecoxib, Vinblastine, Cyclophosphamide , methotrexate , | Drug | traetment |
Primary outcome
Anti-tumour efficacy
Time frame: 3 YEARS
1 secondary outcome
Safety AND Pharmacodynamic Study
Time frame: 3 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Derived from this study: PubMed 30319400Verschuur A, Heng-Maillard MA, Dory-Lautrec P, Truillet R, Jouve E, Chastagner P, Leblond P, Aerts I, Honore S, Entz-Werle N, Sirvent N, Gentet JC, Corradini N, Andre N. Metronomic Four-Drug Regimen Has Anti-tumor Activity in Pediatric Low-Grade Glioma; The Results of a Phase II Clinical Trial. Front Pharmacol. 2018 Sep 27;9:00950. doi: 10.3389/fphar.2018.00950. eCollection 2018.
- Derived from this study: PubMed 22156656Andre N, Abed S, Orbach D, Alla CA, Padovani L, Pasquier E, Gentet JC, Verschuur A. Pilot study of a pediatric metronomic 4-drug regimen. Oncotarget. 2011 Dec;2(12):960-5. doi: 10.18632/oncotarget.358.
Related trials for Survival Without Progression
RecruitingPhase 2
Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients
Bone Sarcoma, Osteosarcoma
RecruitingPhase 3
A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
Renal Cell Carcinoma
RecruitingObservational study
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
Glioblastoma, IDH-wildtype, Glioblastoma
Not yet recruiting
Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection
Meningioma Atypical, Radiotherapy
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.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
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 celecoxib, Vinblastine, Cyclophosphamide , methotrexate , in people with Survival Without Progression, run by Assistance Publique Hopitaux De Marseille 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 13 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumour efficacy (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285817, which also lists 2 linked publications.
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 13 Mar 2023.