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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004224
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Primary Purpose: Treatment
Official Title: SIOP Study of Combined Modality Treatment in Childhood Ependymoma
Study Start Date : January 1999
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Event-free survival
  2. Overall survival
  3. Surgical operability
  4. Response rate

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004224


Locations
Argentina
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
Buenos Aires, Argentina, 1428
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Italy
Fondazione Istituto Nazionale dei Tumori
Milan, Italy, 20133
Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
Spain
Hospital Des Cruces
Vizcaya, Spain, 48
Sweden
Ostra Sjukhuset
Gothenburg, Sweden, 41685
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Italian Association for Pediatric Hematology Oncology
Investigators
Study Chair: Richard Grundy, MD, PhD Birmingham Children's Hospital
Study Chair: Maura Massimino, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
More Information

ClinicalTrials.gov Identifier: NCT00004224     History of Changes
Other Study ID Numbers: CDR0000067465
SIOP-EPENDYMOMA-99
AIEOP-EPENDYMOMA-99
CCLG-EPENDYMOMA-99
EU-99001
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: April 2008

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

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