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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)

Primary Purpose

Survival Without Progression

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survival Without Progression

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%
  • 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

Exclusion Criteria:

  • Pregnant and breast feeding women.
  • Uncontrolled intercurrent illness or active infection
  • Inability to swallow oral medication.
  • Patients on anticonvulsants will be allowed on study

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

traetment

Arm Description

Outcomes

Primary Outcome Measures

Anti-tumour efficacy

Secondary Outcome Measures

Safety AND Pharmacodynamic Study

Full Information

First Posted
January 6, 2011
Last Updated
March 9, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01285817
Brief Title
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.
Acronym
SFCE METRO 01
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 12, 2011 (Actual)
Primary Completion Date
September 11, 2015 (Actual)
Study Completion Date
March 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survival Without Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traetment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
Primary Outcome Measure Information:
Title
Anti-tumour efficacy
Time Frame
3 YEARS
Secondary Outcome Measure Information:
Title
Safety AND Pharmacodynamic Study
Time Frame
3 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% 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 Exclusion Criteria: Pregnant and breast feeding women. Uncontrolled intercurrent illness or active infection Inability to swallow oral medication. Patients on anticonvulsants will be allowed on study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30319400
Citation
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.
Results Reference
derived
PubMed Identifier
22156656
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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