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Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators: Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Associazione Italiana Ematologia Oncologia Pediatrica
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004224
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: cyclophosphamide
Drug: etoposide
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Cyclophosphamide    Etoposide    Vincristine sulfate    Vincristine    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   SIOP Study of Combined Modality Treatment in Childhood Ependymoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Surgical operability [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]

Estimated Enrollment:   65
Study Start Date:   January 1999

Detailed Description:

OBJECTIVES:

  • Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
  • Determine the response rate in these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.

Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.

Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.

Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.

  Eligibility
Ages Eligible for Study:   3 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven nonmetastatic intracranial ependymoma

    • Cellular
    • Papillary
    • Clear cell
    • Mixed cell
    • Anaplastic
  • No myxopapillary ependymoma, subependymoma, or ependymoblastoma

PATIENT CHARACTERISTICS:

Age:

  • 3 to 20

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • No hematologic disease that would preclude study participation

Hepatic:

  • Not specified

Renal:

  • No renal disease that would preclude study participation

Other:

  • No concurrent unrelated disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004224

Locations
Argentina
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia     Recruiting
      Buenos Aires, Argentina, 1428
      Contact: Blanca D. Diez, MD     54-11-5777-3200     bdiez@fleni.org.ar    
Canada, Ontario
Hospital for Sick Children     Recruiting
      Toronto, Ontario, Canada, M5G 1X8
      Contact: Eric Bouffet, MD, MRCP     416-813-7457     eric.bouffet@sickkids.ca    
Italy
Fondazione Istituto Nazionale dei Tumori     Recruiting
      Milan, Italy, 20133
      Contact: Maura Massimino, MD     39-02-239-02-593     maura.massimino@istitutotumori.mi.it    
Netherlands
Erasmus MC - Sophia Children's Hospital     Recruiting
      Rotterdam, Netherlands, 3015 GJ
      Contact: R. Reddingius, MD, PhD     31-10-463-6363        
Spain
Hospital Des Cruces     Recruiting
      Vizcaya, Spain, 48
      Contact: Aurora Navajas     34-94-600-6000        
Sweden
Ostra Sjukhuset     Recruiting
      Gothenburg, Sweden, 41685
      Contact: Brigitta Lannering, MD, PhD     46-31-343-5224        
United Kingdom, England
Birmingham Children's Hospital     Recruiting
      Birmingham, England, United Kingdom, B4 6NH
      Contact: Richard Grundy, MD, PhD     44-121-333-8234     richard.grundy@nottingham.ac.uk    

Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Associazione Italiana Ematologia Oncologia Pediatrica

Investigators
Study Chair:     Richard Grundy, MD, PhD     Birmingham Children's Hospital    
Study Chair:     Richard Grundy, MD, PhD     Birmingham Children's Hospital    
Study Chair:     Maura Massimino, MD     Fondazione Istituto Nazionale dei Tumori    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067465, SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001
First Received:   January 28, 2000
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00004224
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma  
childhood supratentorial ependymoma  
newly diagnosed childhood ependymoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Vincristine
Neuroepithelioma
Cyclophosphamide
Glioma
Central Nervous System Neoplasms
Etoposide phosphate
Etoposide
Ependymoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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