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.
SFCE METRO 01
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).
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
79 participants
Study completion date
March 9, 2023
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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.
Andre 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.
79 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 28, 2011
Study Start
January 12, 2011
Actual (reported)
Primary Completion
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%
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
You may not qualify if:
Pregnant and breast feeding women.
Uncontrolled intercurrent illness or active infection
Inability to swallow oral medication.
Patients on anticonvulsants will be allowed on study
Contact the study team to confirm eligibility.
Azoles
Heterocyclic Compounds, 1-Ring
Heterocyclic Compounds
Vinca Alkaloids
Secologanin Tryptamine Alkaloids
Indole Alkaloids
Alkaloids
Indoles
Heterocyclic Compounds, 2-Ring
Heterocyclic Compounds, Fused-Ring
Indolizidines
Indolizines
Phosphoramide Mustards
Nitrogen Mustard Compounds
Mustard Compounds
Hydrocarbons, Halogenated
Phosphoramides
Organophosphorus Compounds
Aminopterin
Pterins
Pteridines
September 11, 2015
Actual (reported)
Study Completion
March 9, 2023
Actual (reported)
Last Updated
March 13, 2023
Record last verified: 2015-10
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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