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

This study is ongoing, but not recruiting participants.

Sponsored by: New York University School of Medicine
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003273
  Purpose

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

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Bone Marrow Transplantation    Brain Cancer    Cancer    Childhood Brain Tumors    Neuroblastoma    Soft Tissue Sarcoma   

ChemIDplus related topics:   Cyclophosphamide    Carboplatin    Filgrastim    Etoposide    Cisplatin    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Vincristine sulfate    Vincristine    Temozolomide    Thiotepa    Etoposide phosphate    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

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

Estimated Enrollment:   96
Study Start Date:   November 1997

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Under 10 at diagnosis

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 for the sole purpose of antiemesis

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003273

Locations
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
Beth Israel Hospital North    
      New York, New York, United States, 10128
Herbert Irving Comprehensive Cancer Center    
      New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center    
      New York, New York, United States, 10016
State University of New York - Upstate Medical University    
      Syracuse, New York, United States, 13210
State University of New York Health Sciences Center - Stony Brook    
      Stony Brook, New York, United States, 11790-7775
Winthrop University Hospital    
      Mineola, New York, United States, 11501
United States, Ohio
St. Vincent Mercy Medical Center    
      Toledo, Ohio, United States, 43608
United States, Pennsylvania
Children's Hospital of Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104
Milton S. Hershey Medical Center    
      Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792-6164
Argentina
Children's Hospital    
      Buenos Aires, Argentina, 1425
Canada, British Columbia
British Columbia Children's Hospital    
      Vancouver, British Columbia, Canada, V6H 3V4

Sponsors and Collaborators
New York University School of Medicine

Investigators
Study Chair:     Jonathan L. Finlay, MB, ChB     New York University School of Medicine    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066174, NYU-P9712, NCI-V98-1400
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00003273
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Retinal Neoplasms
Choroid Plexus Neoplasms
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Leucovorin
Cyclophosphamide
Central Nervous System Neoplasms
Brain Diseases
Retinoblastoma
Etoposide phosphate
Ependymoma
Neuroblastoma
Soft tissue sarcomas
Cisplatin
Neoplasms, Germ Cell and Embryonal
Methotrexate
Neuroepithelioma
Choroid Plexus neoplasms
Etoposide
Nervous System Neoplasms
Retinal Diseases
Rhabdomyosarcoma
Eye Neoplasms
Eye Diseases
Vincristine
Central Nervous System Diseases
Carboplatin
Temozolomide
Thiotepa
Folic Acid

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Reproductive Control Agents
Neoplasms by Site
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Growth Substances
Mitosis Modulators
Nervous System Diseases
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Tubulin Modulators
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 16, 2008




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