Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00514397
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- 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.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
* To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.
Secondary
* To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
* To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group.
* To document radiological response to the above treatment with MR imaging and, where available, functional imaging.
OUTLINE: This is a multicenter study.
* Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days per week) with concurrent radiotherapy (5 days per week).
Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy.
* Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide.
After completion of study therapy, patients are followed every 8 weeks.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
- Secondary Outcome Measures
Name Time Method Toxicity, steroid usage, and radiological response Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Trial Locations
- Locations (20)
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
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