Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
4 other identifiers
interventional
43
2 countries
21
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 9, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedAugust 12, 2013
June 1, 2009
August 8, 2007
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
Secondary Outcomes (2)
Toxicity, steroid usage, and radiological response
Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Interventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI
- No requirement for histological diagnosis
- Clinical history \< 6 months
- Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:
- Cranial nerve deficit
- Long tract signs
- Ataxia
You may not qualify if:
- Focal lesions of brainstem
- Predominantly exophytic tumors
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)
- Life expectancy \> 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Urea and serum creatinine \< 1.5 times upper limit of normal (ULN)
- Total and direct bilirubin \< 1.5 times ULN
- AST and ALT \< 3 times ULN
- Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential
- Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Pregnant or breast-feeding women
- PRIOR CONCURRENT THERAPY:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12, Ireland
Birmingham Children's Hospital
Birmingham, England, B4 6NH, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, BS2 8AE, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, England, LE1 5WW, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP, United Kingdom
University College Hospital
London, England, NW1 2BU, United Kingdom
Great Ormond Street Hospital for Children
London, England, WC1N 3JH, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, M27 4HA, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP, United Kingdom
Queen's Medical Centre
Nottingham, England, NG7 2UH, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, S10 2TH, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Royal Marsden - Surrey
Sutton, England, SM2 5PT, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Bailey, MD
Sir James Spence Institute of Child Health at Royal Victoria Infirmary