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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
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes
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
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Radiation Therapy Surgery
Drug Information available for: Cyclophosphamide Vincristine Etoposide Vincristine sulfate
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 IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067465, SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001
Study First Received: January 28, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004224     History of Changes
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:
Immunologic Factors
Adjuvants, Immunologic
Vincristine
Antimitotic Agents
Central Nervous System Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Etoposide phosphate
Ependymoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Neuroepithelioma
Antineoplastic Agents, Alkylating
Glioma
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Etoposide
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Cyclophosphamide
Ependymoma
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Alkylating Agents
Nervous System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009