Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313521
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-04-11
Brief Title:
Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_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 thiotepa 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 chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors
PURPOSE This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors
Detailed Description:
OBJECTIVES
Primary
Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors
Secondary
Determine the acute and chronic toxicity of thiotepa in these patients
Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients
Develop a phase II study framework model to determine the chemosensitivity to new single-agent regimens in the treatment of high-grade malignant astrocytic tumors including anaplastic astrocytoma glioblastoma giant cell glioblastoma and gliosarcoma
Determine the incidence of distant neuraxial metastases in patients at the time of relapse
Determine the 1-year disease-free survival rate in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified by age 3-15 vs 16-20 years of age
Chemotherapy Patients receive thiotepa IV continuously over 168 hours on days 1-7 Treatment repeats every 28 days for up to 2 courses Patients then proceed to radiotherapy after blood counts recover
Radiotherapy Patients undergo external-beam radiotherapy once daily 5 days a week for approximately 6 weeks
Post-radiation chemotherapy Patients with complete partial or objective response or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors
Secondary
Determine the acute and chronic toxicity of thiotepa in these patients
Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients
Develop a phase II study framework model to determine the chemosensitivity to new single-agent regimens in the treatment of high-grade malignant astrocytic tumors including anaplastic astrocytoma glioblastoma giant cell glioblastoma and gliosarcoma
Determine the incidence of distant neuraxial metastases in patients at the time of relapse
Determine the 1-year disease-free survival rate in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified by age 3-15 vs 16-20 years of age
Chemotherapy Patients receive thiotepa IV continuously over 168 hours on days 1-7 Treatment repeats every 28 days for up to 2 courses Patients then proceed to radiotherapy after blood counts recover
Radiotherapy Patients undergo external-beam radiotherapy once daily 5 days a week for approximately 6 weeks
Post-radiation chemotherapy Patients with complete partial or objective response or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| CCLG-CNS-1995-01 | None | None | None |
| CCLG-9405 | None | None | None |
| EU-20575 | None | None | None |