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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: January 6, 2011
Last updated: October 22, 2015
Last verified: October 2015

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).

Condition Intervention Phase
Solid Tumours.
Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Anti-tumour efficacy [ Time Frame: 3 YEARS ]

Secondary Outcome Measures:
  • Safety AND Pharmacodynamic Study [ Time Frame: 3 YEARS ]

Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: traetment Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,

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)


Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01285817

Contact: ARNAUD VERSCHUUR 04 91 38 84 78

Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: arnaud verschuur   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01285817     History of Changes
Other Study ID Numbers: 2010-12
2010-021792-81 ( EudraCT Number )
Study First Received: January 6, 2011
Last Updated: October 22, 2015

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents processed this record on May 25, 2017