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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00281905
First received: January 24, 2006
Last updated: September 19, 2013
Last verified: June 2007
  Purpose

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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Children Aged Less Than 3 Years With Brain Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Local recurrence or occurrence of CNS metastases [ Designated as safety issue: No ]
  • Quality of survival [ Designated as safety issue: No ]
  • Tolerance [ Designated as safety issue: Yes ]
  • Long-term toxicity [ Designated as safety issue: Yes ]
  • Proportion of patients requiring radiotherapy [ Designated as safety issue: No ]
  • Prognosis of children who receive both chemotherapy and radiotherapy [ Designated as safety issue: No ]
  • Nature and behavior of brain tumors [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 1992
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

    • Concurrent steroids allowed for control of tumor-related symptoms
  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: NCT00281905

Locations
Ireland
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
Investigators
Study Chair: Richard Grundy, MD, PhD Queen's Medical Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00281905     History of Changes
Other Study ID Numbers: CDR0000454575, CCLG-CNS-9204, EU-20574, CCLG-CNS-1992-04
Study First Received: January 24, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
untreated childhood cerebellar astrocytoma
childhood choroid plexus tumor
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
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:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neuroblastoma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Cyclophosphamide
Methotrexate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 22, 2014