Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006258
First received: September 11, 2000
Last updated: July 17, 2013
Last verified: December 2004
  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 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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Study Start Date: November 1997
Study Completion Date: January 2005
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 10 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

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

Renal:

  • Creatinine clearance greater than 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed
  • No concurrent corticosteroids as antiemetics

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  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: NCT00006258

Locations
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
Investigators
Study Chair: Jonathan L. Finlay, MB, ChB Children's Hospital Los Angeles
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006258     History of Changes
Other Study ID Numbers: CHLA-NYU-0002H, CDR0000068192, NYU-0027H, NCI-G00-1852
Study First Received: September 11, 2000
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

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:
Ependymoma
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Cisplatin
Cyclophosphamide
Etoposide
Methotrexate
Vincristine
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on July 24, 2014