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

Primary Purpose

Brain and Central Nervous System Tumors, Neuroblastoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
cisplatin
cyclophosphamide
methotrexate
vincristine sulfate
radiation therapy
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children
  • Birmingham Children's Hospital
  • Institute of Child Health at University of Bristol
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Royal London Hospital
  • Great Ormond Street Hospital for Children NHS Trust
  • Central Manchester and Manchester Children's University Hospitals NHS Trust
  • Sir James Spence Institute of Child Health
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Royal Belfast Hospital for Sick Children
  • Royal Aberdeen Children's Hospital
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children
  • Childrens Hospital for Wales

Outcomes

Primary Outcome Measures

Response rate
Event-free survival
Local recurrence or occurrence of CNS metastases
Quality of survival
Tolerance
Long-term toxicity
Proportion of patients requiring radiotherapy
Prognosis of children who receive both chemotherapy and radiotherapy
Nature and behavior of brain tumors

Secondary Outcome Measures

Full Information

First Posted
January 24, 2006
Last Updated
September 19, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00281905
Brief Title
Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors
Official Title
Management of Children Aged Less Than 3 Years With Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Neuroblastoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Response rate
Title
Event-free survival
Title
Local recurrence or occurrence of CNS metastases
Title
Quality of survival
Title
Tolerance
Title
Long-term toxicity
Title
Proportion of patients requiring radiotherapy
Title
Prognosis of children who receive both chemotherapy and radiotherapy
Title
Nature and behavior of brain tumors

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Grundy, MD, PhD
Organizational Affiliation
Queen's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Central Manchester and Manchester Children's University Hospitals NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

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

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