Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433381
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2007-02-08
Brief Title:
Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as irinotecan and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with irinotecan or temozolomide may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of bevacizumab and irinotecan hydrochloride in terms of 6-month progression-free survival rate in patients with recurrent or refractory intracranial glioblastoma multiforme or gliosarcoma
II Determine the adverse event profile and tolerability of bevacizumab and temozolomide in these patients
SECONDARY OBJECTIVES
I Determine the efficacy of bevacizumab and temozolomide in terms of 6-month progression-free survival rate in patients previously treated with temozolomide
II Determine the efficacy of bevacizumab and irinotecan hydrochloride in terms of objective response in patients with measurable disease
III Determine the efficacy of bevacizumab and temozolomide in terms of objective response in patients with measurable disease who were previously treated with temozolomide
IV Determine the toxicity profile and tolerability of bevacizumab and irinotecan hydrochloride in these patients
TERTIARY OBJECTIVES
I Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as an early indicator of response to therapy after 2 weeks of treatment with bevacizumab
II Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as a prognostic indicator based on images taken at baseline at 2 weeks and after 2 courses of study treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to age 50 vs 50 years of age and Karnofsky performance status 70-80 vs 90-100 Patients are randomized to 1 of 2 treatment arms with a 21 ratio arm Iarm II
ARM I Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21
ARM II Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15
In both arms treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity All patients undergo MRI at baseline and at every 2 courses no 2-week MRI per standard of care until progression or discontinuation of treatment to assess areas of breakdown of the blood-brain barrier Patients undergo an additional MRI after study therapy Consenting patients also undergo diffusion and perfusion MRI and magnetic resonance spectroscopic imaging for correlative studies
After completion of study therapy patients are followed up for at least 1 month
I Determine the efficacy of bevacizumab and irinotecan hydrochloride in terms of 6-month progression-free survival rate in patients with recurrent or refractory intracranial glioblastoma multiforme or gliosarcoma
II Determine the adverse event profile and tolerability of bevacizumab and temozolomide in these patients
SECONDARY OBJECTIVES
I Determine the efficacy of bevacizumab and temozolomide in terms of 6-month progression-free survival rate in patients previously treated with temozolomide
II Determine the efficacy of bevacizumab and irinotecan hydrochloride in terms of objective response in patients with measurable disease
III Determine the efficacy of bevacizumab and temozolomide in terms of objective response in patients with measurable disease who were previously treated with temozolomide
IV Determine the toxicity profile and tolerability of bevacizumab and irinotecan hydrochloride in these patients
TERTIARY OBJECTIVES
I Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as an early indicator of response to therapy after 2 weeks of treatment with bevacizumab
II Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as a prognostic indicator based on images taken at baseline at 2 weeks and after 2 courses of study treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to age 50 vs 50 years of age and Karnofsky performance status 70-80 vs 90-100 Patients are randomized to 1 of 2 treatment arms with a 21 ratio arm Iarm II
ARM I Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21
ARM II Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15
In both arms treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity All patients undergo MRI at baseline and at every 2 courses no 2-week MRI per standard of care until progression or discontinuation of treatment to assess areas of breakdown of the blood-brain barrier Patients undergo an additional MRI after study therapy Consenting patients also undergo diffusion and perfusion MRI and magnetic resonance spectroscopic imaging for correlative studies
After completion of study therapy patients are followed up for at least 1 month
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 |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2009-00743 | REGISTRY | None | None |
| RTOG-0625 | OTHER | None | None |
| ACRIN-6677 | OTHER | None | None |
| CDR0000528259 | REGISTRY | None | None |
| RTOG 0625 | OTHER | None | None |
| RTOG-0625 | OTHER | None | None |