Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01019434
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2009-11-24
Brief Title:
Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Radiation Therapy and Concurrent Plus Adjuvant Temsirolimus CCI-779 Versus Chemo-Irradiation With Temozolomide in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Gene Promoter - A Randomized Multicenter Open-Label Phase II Study
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
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 Radiation therapy uses high-energy x-rays to kill tumor cells Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 It is not yet known whether radiation therapy is more effective when given together with temsirolimus or temozolomide in treating patients with glioblastoma
PURPOSE This randomized phase II trial is studying giving radiation therapy together with temsirolimus to see how well it works compared with giving radiation therapy together with temozolomide in treating patients with newly diagnosed glioblastoma
PURPOSE This randomized phase II trial is studying giving radiation therapy together with temsirolimus to see how well it works compared with giving radiation therapy together with temozolomide in treating patients with newly diagnosed glioblastoma
Detailed Description:
OBJECTIVES
Primary
Document the activity profile of temsirolimus by the evaluation of overall survival at 1 year in patients with newly diagnosed glioblastoma multiforme without methylation of the MGMT gene promoter treated with temsirolimus before and concomitantly with radiotherapy followed by temsirolimus maintenance therapy
Secondary
Investigate safety and tolerability of this therapy regimen in these patients
Assess progression-free survival and overall survival of these patients
Assess biomarkers in the tumor tissue relevant to temsirolimus and disease state and their correlation to clinical outcome in these patients
OUTLINE This is a multicenter study Patients are stratified according to institution age in years 50 vs 50 Karnofsky performance status PS 80 vs 80 OR ECOG PS 0 or 1 vs 2 and corticosteroid use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Within 7 weeks after surgery or open biopsy patients undergo radiotherapy 5 days a week for 6 weeks and receive oral temozolomide concurrently once daily for 6 weeks Beginning 4 weeks after completion of concurrent chemoradiotherapy patients receive adjuvant oral temozolomide once daily on days 1-5 Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression and unacceptable toxicity
Arm II Within 7 weeks after surgery or open biopsy patients undergo radiotherapy 5 days a week for 6 weeks Patients also receive temsirolimus IV over 30-60 minutes once weekly beginning 7 days before initiation of radiotherapy After completion of chemoradiotherapy patients receive maintenance temsirolimus IV once weekly in the absence of disease progression and unacceptable toxicity
Frozen tumor biopsies or paraffin-embedded tumor material obtained from surgery or open biopsy and blood samples are collected for analysis of molecular markers determination of the methylation status of the MGMT gene promoter before randomization and at a later time and other studies
After completion of study therapy patients are followed every 3 months
Primary
Document the activity profile of temsirolimus by the evaluation of overall survival at 1 year in patients with newly diagnosed glioblastoma multiforme without methylation of the MGMT gene promoter treated with temsirolimus before and concomitantly with radiotherapy followed by temsirolimus maintenance therapy
Secondary
Investigate safety and tolerability of this therapy regimen in these patients
Assess progression-free survival and overall survival of these patients
Assess biomarkers in the tumor tissue relevant to temsirolimus and disease state and their correlation to clinical outcome in these patients
OUTLINE This is a multicenter study Patients are stratified according to institution age in years 50 vs 50 Karnofsky performance status PS 80 vs 80 OR ECOG PS 0 or 1 vs 2 and corticosteroid use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Within 7 weeks after surgery or open biopsy patients undergo radiotherapy 5 days a week for 6 weeks and receive oral temozolomide concurrently once daily for 6 weeks Beginning 4 weeks after completion of concurrent chemoradiotherapy patients receive adjuvant oral temozolomide once daily on days 1-5 Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression and unacceptable toxicity
Arm II Within 7 weeks after surgery or open biopsy patients undergo radiotherapy 5 days a week for 6 weeks Patients also receive temsirolimus IV over 30-60 minutes once weekly beginning 7 days before initiation of radiotherapy After completion of chemoradiotherapy patients receive maintenance temsirolimus IV once weekly in the absence of disease progression and unacceptable toxicity
Frozen tumor biopsies or paraffin-embedded tumor material obtained from surgery or open biopsy and blood samples are collected for analysis of molecular markers determination of the methylation status of the MGMT gene promoter before randomization and at a later time and other studies
After completion of study therapy patients are followed every 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-003003-31 | EUDRACT_NUMBER | None | None |
| EORTC-26082 | None | None | None |
| EORTC-22081 | None | None | None |
| EU-20987 | None | None | None |