Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
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|ClinicalTrials.gov Identifier: NCT00514397|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 9, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: motexafin gadolinium Drug: temozolomide Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Official Title:||A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas|
|Study Start Date :||January 2008|
- Overall survival
- Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
- Toxicity, steroid usage, and radiological response
- Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
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 ClinicalTrials.gov identifier (NCT number): NCT00514397
|Our Lady's Hospital for Sick Children Crumlin||Recruiting|
|Dublin, Ireland, 12|
|Contact: Contact Person 44-353-1-409-6659|
|Birmingham Children's Hospital||Recruiting|
|Birmingham, England, United Kingdom, B4 6NH|
|Contact: Martin W. English, MD 44-121-333-8412 firstname.lastname@example.org|
|Bristol Royal Hospital for Children||Recruiting|
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|Contact: Contact Person 44-117-342-0205|
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|Contact: Amos Burke, MD 44-1223-348-151|
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
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|Leicester Royal Infirmary||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: Johann Visser, MD 44-116-258-5309 firstname.lastname@example.org|
|Royal Liverpool Children's Hospital, Alder Hey||Recruiting|
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|Contact: Contact Person 44-151-252-5294|
|University College Hospital||Recruiting|
|London, England, United Kingdom, NW1 2BU|
|Contact: Contact Person 44-20-7380-9950|
|Great Ormond Street Hospital for Children||Recruiting|
|London, England, United Kingdom, WC1N 3JH|
|Contact: Contact Person 44-20-7829-7924|
|Royal Manchester Children's Hospital||Recruiting|
|Manchester, England, United Kingdom, M27 4HA|
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|Sir James Spence Institute of Child Health at Royal Victoria Infirmary||Recruiting|
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|Queen's Medical Centre||Recruiting|
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|Oxford Radcliffe Hospital||Recruiting|
|Oxford, England, United Kingdom, 0X3 9DU|
|Contact: Contact Person 44-1865-234-205|
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|Sheffield, England, United Kingdom, S10 2TH|
|Contact: Contact Person 44-114-271-7366|
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|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
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|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
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|Childrens Hospital for Wales||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 4XW|
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|Principal Investigator:||Simon Bailey, MD||Sir James Spence Institute of Child Health at Royal Victoria Infirmary|