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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

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: NCT00003273
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Neuroblastoma Retinoblastoma Sarcoma Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: temozolomide Drug: thiotepa Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa, Etoposide and Carboplatin) and Autologous Stem Cell Rescue
Study Start Date : November 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant, newly diagnosed brain tumor

Regimen A:

  • Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET):

    • All stages, under 3 years at diagnosis OR
    • High stage (local residual tumor postoperatively and/or neuraxis or extraneural dissemination), 3-10 years at diagnosis
  • Supratentorial PNET, pineoblastoma, cerebral neuroblastoma, ependymoblastoma, medulloepithelioma, medullomyoblastoma:

    • All stages, under 10 years at diagnosis
  • Brainstem PNET:

    • All stages, irrespective of extent of resection, under 10 years at diagnosis
  • Ependymoma or anaplastic ependymoma:

    • All stages, any location (except primary spinal cord ependymoma), under 3 years at diagnosis OR
    • Local residual tumor postoperatively and/or neuraxis dissemination, any location, 3-10 years at diagnosis
  • Supratentorial ependymoma:

    • All stages, irrespective of extent of resection, under 10 years at diagnosis, excluding gross totally resected (confirmed by postoperative MRI) low grade ependymoma not invading the ventricular system
  • Metastatic retinoblastoma:

    • Previously untreated (except for cryosurgery or laser surgery), under 10 years at presentation of metastatic disease
  • Primary atypical teratoid/rhabdoid tumors of the CNS:

    • Under 10 years at diagnosis
  • Choroid plexus carcinoma:

    • Incompletely resected, all sites, under 10 years at diagnosis

Regimen C:

  • Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic ganglioglioma, other anaplastic mixed gliomas:

    • Under 10 years at diagnosis
  • Diffuse intrinsic pontine tumors:

    • Unbiopsied, under 10 years at diagnosis

The following diagnoses are not eligible:

  • Myxopapillary ependymoma of the spinal cord, low grade brainstem astrocytoma, primary CNS lymphoma or solid leukemic lesion (i.e., chloroma, granulocytic sarcoma), or primary CNS germ cell tumor



  • Under 10 at diagnosis

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 for the sole purpose of antiemesis


  • No prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery

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): NCT00003273

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United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maine
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Michigan
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
Winthrop University Hospital
Mineola, New York, United States, 11501
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Beth Israel Hospital North
New York, New York, United States, 10128
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, Ohio
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Children's Hospital
Buenos Aires, Argentina, 1425
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
NYU Langone Health
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Study Chair: Jonathan L. Finlay, MB, ChB NYU Langone Health

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Responsible Party: NYU Langone Health Identifier: NCT00003273     History of Changes
Other Study ID Numbers: CDR0000066174
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: November 2015
Keywords provided by NYU Langone Health:
childhood infratentorial ependymoma
childhood supratentorial ependymoma
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
extraocular retinoblastoma
childhood choroid plexus tumor
localized unresectable neuroblastoma
previously untreated childhood rhabdomyosarcoma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood medulloblastoma
newly diagnosed childhood ependymoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases
Etoposide phosphate
Antineoplastic Agents
Immunosuppressive Agents