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Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or 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. Identifier: NCT00006258
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: methotrexate Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected, newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
  • Determine the response rate, time to progression, overall survival, and pattern of failure in these patients treated with this regimen.

OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy.

Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation
Study Start Date : November 1997
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histological confirmation of one of the following:

    • High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater)
    • Primitive neuroectodermal tumor
    • Ependymoma

      • Incompletely resected on postoperative MRI or neurosurgical report
  • Definitive prior surgery within 42 days of study



  • 10 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin less than 1.5 mg/dL
  • SGPT less than 2.5 times upper limit of normal


  • Creatinine clearance greater than 60 mL/min


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed
  • No concurrent corticosteroids as antiemetics


  • No prior radiotherapy


  • See Disease Characteristics

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 identifier (NCT number): NCT00006258

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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Children's Hospital Los Angeles
National Cancer Institute (NCI)
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Study Chair: Jonathan L. Finlay, MB, ChB Children's Hospital Los Angeles

Publications of Results:
Layout table for additonal information Identifier: NCT00006258     History of Changes
Other Study ID Numbers: CHLA-NYU-0002H
CDR0000068192 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: December 2004
Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
adult medulloblastoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult ependymoblastoma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood medulloblastoma
newly diagnosed childhood ependymoma
adult supratentorial primitive neuroectodermal tumor (PNET)
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents