Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514397
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2007-08-08
Brief Title:
Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2007-001768-60 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000560114 | REGISTRY | None | None |
| EU-20746 | None | None | None |