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Trial record 14 of 15 for:    "Ependymoma" | "Methotrexate"

Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

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: NCT00281905
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 25, 2006
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Neuroblastoma Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: methotrexate Drug: vincristine sulfate Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
  • Determine the event-free survival and overall survival in children treated with this regimen.
  • Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
  • Determine the quality of life in children treated with this regimen.
  • Determine the tolerability and long-term toxicity of this regimen in these children.
  • Determine the proportion of children who require radiotherapy after treatment with this regimen.
  • Determine the prognosis of children who receive both chemotherapy and radiotherapy.
  • Determine the nature and behavior of brain tumors in very young children.

OUTLINE: This is a multicenter study.

  • Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.
  • Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.
  • Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Children Aged Less Than 3 Years With Brain Tumors
Study Start Date : June 1992

Primary Outcome Measures :
  1. Response rate
  2. Event-free survival
  3. Local recurrence or occurrence of CNS metastases
  4. Quality of survival
  5. Tolerance
  6. Long-term toxicity
  7. Proportion of patients requiring radiotherapy
  8. Prognosis of children who receive both chemotherapy and radiotherapy
  9. Nature and behavior of brain tumors

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of 1 of the following:

    • Brain stem tumor (histological confirmation not required)
    • Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:

      • Anaplastic (malignant) astrocytoma
      • Glioblastoma
      • Anaplastic (malignant) oligodendroglioma
      • Ependymoma
      • Anaplastic (malignant) ependymoma
      • Anaplastic (malignant) oligoastrocytoma
      • Choroid plexus carcinoma
      • Astroblastoma
      • Polar spongioblastoma
      • Gliomatosis cerebri
      • Anaplastic (malignant) ganglioglioma
      • Pineoblastoma
      • Mixed pineocytoma or pineoblastoma
      • Medulloepithelioma
      • Neuroblastoma
      • Ependymoblastoma
      • Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs
  • Has undergone surgery or biopsy of the tumor within the past 2-4 weeks


  • No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment


  • No prior chemotherapy or radiotherapy
  • Prior steroids allowed
  • No concurrent steroids as anti-emetics

    • Concurrent steroids allowed for control of tumor-related symptoms

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): NCT00281905

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Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
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Study Chair: Richard Grundy, MD, PhD Queen's Medical Centre

Layout table for additonal information Identifier: NCT00281905     History of Changes
Other Study ID Numbers: CDR0000454575
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: June 2007
Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
untreated childhood brain stem glioma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
untreated childhood cerebellar astrocytoma
childhood choroid plexus tumor
untreated childhood medulloblastoma
childhood oligodendroglioma
untreated childhood supratentorial primitive neuroectodermal tumor
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
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
Reproductive Control Agents