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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.
Verified January 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01285817
First received: January 6, 2011
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Tumors
 Drug: celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Anti-tumour efficacy [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety AND Pharmacodynamic Study [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (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)

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285817

Contacts
Contact: ARNAUD VERSCHUUR 04 91 38 84 78 arnaud.verschuur@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: arnaud verschuur         arnaud.verschuur@ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bernard BELAIGUES, direction de la recherche
ClinicalTrials.gov Identifier: NCT01285817     History of Changes
Other Study ID Numbers: 2010-12, 2010-021792-81
Study First Received: January 6, 2011
Last Updated: January 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Cyclophosphamide
Methotrexate
Vinblastine
Celecoxib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013