Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278278
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2006-01-16
Brief Title:
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
Sponsor:
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma
Status:
UNKNOWN
Status Verified Date:
2008-11
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells It is not yet known whether giving methotrexate together with combination chemotherapy and radiation therapy is more effective than combination chemotherapy and radiation therapy alone in treating gliomas
PURPOSE This randomized phase III trial is studying giving methotrexate together with combination chemotherapy and radiation therapy to see how well it works compared to combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas
PURPOSE This randomized phase III trial is studying giving methotrexate together with combination chemotherapy and radiation therapy to see how well it works compared to combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas
Detailed Description:
OBJECTIVES
Primary
Determine if the addition of high-dose methotrexate prior to standard treatment improves survival of patients with malignant high-grade glioma or diffuse intrinsic pontine glioma as compared to standard treatment only
Secondary
Determine if the addition of high-dose methotrexate as compared to standard treatment only improves the tumor response of these patients
Determine if high-dose methotrexate compared to standard treatment only improves the progression-free or event-free survival of these patients
Determine if high-dose methotrexate as compared to standard treatment only improves the health status quality of life of these patients
Determine if consolidation therapy improves the overall progression-free or event-free survival rates as compared to the historical control group
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor location includes pons yes vs no and complete or nearly complete resection yes vs no
Surgery All patients are encouraged to undergo radical resection of the tumor to reduce intracranial pressure remove as much tumor tissue as possible and obtain tumor tissue for histological diagnosis Within 14 days after surgery patients proceed to induction chemotherapy
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I
High-dose methotrexate with leucovorin calcium Patients receive high-dose methotrexate IV over 24 hours on days 1 and 15 and leucovorin calcium IV every 6 hours on days 2-3 an 16-17 Patients proceed to chemoradiotherapy 4 weeks later
Chemoradiotherapy course 1 Patients undergo external beam radiotherapy once daily 5 days a week for approximately 6 weeks Beginning on the first day of radiotherapy patients receive cisplatin IV over 1 hour on days 1-5 etoposide IV over 2 hours on days 1-3 and vincristine IV on days 5 12 19 26 and 33 Patients proceed to course 2 of chemoradiotherapy 7 days prior to completion of radiotherapy
Chemoradiotherapy course 2 Patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5 etoposide IV over 2 hours on days 1-3 and vincristine IV on day 5 Patients proceed to consolidation chemotherapy 4 weeks later
Arm II Patients receive chemoradiotherapy courses 1 and 2 as in arm I and proceed to consolidation chemotherapy 4 weeks later
Consolidation chemotherapy Patients receive vincristine IV on days 1 8 and 15 oral lomustine once on day 2 and oral prednisone once daily on days 1-17 Treatment repeats every 6 weeks for up to 8 courses
Quality of life is assessed 1 week after surgery after completion of chemoradiotherapy at 1 4 and 13 months after completion of consolidation chemotherapy and then annually for 3 years
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
Primary
Determine if the addition of high-dose methotrexate prior to standard treatment improves survival of patients with malignant high-grade glioma or diffuse intrinsic pontine glioma as compared to standard treatment only
Secondary
Determine if the addition of high-dose methotrexate as compared to standard treatment only improves the tumor response of these patients
Determine if high-dose methotrexate compared to standard treatment only improves the progression-free or event-free survival of these patients
Determine if high-dose methotrexate as compared to standard treatment only improves the health status quality of life of these patients
Determine if consolidation therapy improves the overall progression-free or event-free survival rates as compared to the historical control group
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor location includes pons yes vs no and complete or nearly complete resection yes vs no
Surgery All patients are encouraged to undergo radical resection of the tumor to reduce intracranial pressure remove as much tumor tissue as possible and obtain tumor tissue for histological diagnosis Within 14 days after surgery patients proceed to induction chemotherapy
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I
High-dose methotrexate with leucovorin calcium Patients receive high-dose methotrexate IV over 24 hours on days 1 and 15 and leucovorin calcium IV every 6 hours on days 2-3 an 16-17 Patients proceed to chemoradiotherapy 4 weeks later
Chemoradiotherapy course 1 Patients undergo external beam radiotherapy once daily 5 days a week for approximately 6 weeks Beginning on the first day of radiotherapy patients receive cisplatin IV over 1 hour on days 1-5 etoposide IV over 2 hours on days 1-3 and vincristine IV on days 5 12 19 26 and 33 Patients proceed to course 2 of chemoradiotherapy 7 days prior to completion of radiotherapy
Chemoradiotherapy course 2 Patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5 etoposide IV over 2 hours on days 1-3 and vincristine IV on day 5 Patients proceed to consolidation chemotherapy 4 weeks later
Arm II Patients receive chemoradiotherapy courses 1 and 2 as in arm I and proceed to consolidation chemotherapy 4 weeks later
Consolidation chemotherapy Patients receive vincristine IV on days 1 8 and 15 oral lomustine once on day 2 and oral prednisone once daily on days 1-17 Treatment repeats every 6 weeks for up to 8 courses
Quality of life is assessed 1 week after surgery after completion of chemoradiotherapy at 1 4 and 13 months after completion of consolidation chemotherapy and then annually for 3 years
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 150 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 |
|---|---|---|---|
| EU-205100 | None | None | None |
| GPOH-HIT-GBM-D | None | None | None |