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

This study has been completed.
Sponsor:
Collaborators:
Children's Cancer and Leukaemia Group
Italian Association for Pediatric Hematology Oncology
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004224
First received: January 28, 2000
Last updated: August 23, 2013
Last verified: April 2008
  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 2

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

Resource links provided by NLM:


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
Study Completion Date: March 2008
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
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 ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004224     History of Changes
Other Study ID Numbers: CDR0000067465, SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001
Study First Received: January 28, 2000
Last Updated: August 23, 2013
Health Authority: Unspecified

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
Vincristine
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
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 19, 2014