Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085254
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2004-06-10
Brief Title:
Cilengitide Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Safety Run-inRandomized Phase II Trial of EMD 121974 in Conjunction With Concomitant and Adjuvant Temozolomide With Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2015-10
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:
Cilengitide may stop the growth of cancer by stopping blood flow to the tumor 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 damage tumor cells Giving cilengitide together with temozolomide and radiation therapy may kill more tumor cells This randomized phase III trial is studying the side effects and best dose of cilengitide when given together with temozolomide and radiation therapy and to compare how well they work in treating patients with newly diagnosed glioblastoma multiforme
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety profile of EMD 121974 cilengitide when administered as a one-hour infusion twice a week concurrently with concomitant and adjuvant temozolomide with radiation therapy for newly diagnosed glioblastoma multiforme Safety Run-In
II To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy Phase II
SECONDARY OBJECTIVES
I To estimate and compare overall survival between a low dose treatment group and a high dose treatment group in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy Phase II
II To determine the toxicity of EMD 121974 cilengitide when it is administered in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme Phase II
III To evaluate the molecular profile of individual patients and correlate molecular expression profiles with clinical outcomes Phase II
IV To characterize tumor blood volume tumor blood flow and permeability ratios using perfusion MR in newly diagnosed glioblastoma multiforme and follow these parameters during treatment with EMD 121974 cilengitide Phase II
OUTLINE This is an open-label multicenter safety run-in study of cilengitide followed by a randomized phase II study
Safety Run-In
INITIATION COURSE Patients receive cilengitide IV over 1 hour on days 1 and 4 Treatment repeats weekly for 10 weeks Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6
MAINTENANCE COURSES Patients receive oral temozolomide once daily on days 1-5 in courses 1-6 Patients also receive cilengitide IV on days 1 4 8 11 15 18 22 and 25 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cilengitide 3 Pre-defined study dose levels are defined as 500 1000 and 2000mg The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity If no MTD maximum tolerable dose is defined through three steps of the dose escalation process we will pursue the phase II safetyefficacy study with randomized treatment allocation Patients will be randomized into one of two pre-specified treatment dosage arms 500mg group or 2000mg group
PHASE II
Patients are stratified according to age 50 and under vs over 50 Karnofsky performance score 60-80 vs 90-100 and tumor status measurable vs nonmeasurable Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the lower dose as in safety run-in initiation and maintenance courses
ARM II Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the higher dose as in safety run-in initiation and maintenance courses
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 9-112 patients 9-18 for safety run-in and 94 47 per treatment arm for phase II will be accrued for this study within 15-37 months
I To assess the safety profile of EMD 121974 cilengitide when administered as a one-hour infusion twice a week concurrently with concomitant and adjuvant temozolomide with radiation therapy for newly diagnosed glioblastoma multiforme Safety Run-In
II To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy Phase II
SECONDARY OBJECTIVES
I To estimate and compare overall survival between a low dose treatment group and a high dose treatment group in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy Phase II
II To determine the toxicity of EMD 121974 cilengitide when it is administered in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme Phase II
III To evaluate the molecular profile of individual patients and correlate molecular expression profiles with clinical outcomes Phase II
IV To characterize tumor blood volume tumor blood flow and permeability ratios using perfusion MR in newly diagnosed glioblastoma multiforme and follow these parameters during treatment with EMD 121974 cilengitide Phase II
OUTLINE This is an open-label multicenter safety run-in study of cilengitide followed by a randomized phase II study
Safety Run-In
INITIATION COURSE Patients receive cilengitide IV over 1 hour on days 1 and 4 Treatment repeats weekly for 10 weeks Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6
MAINTENANCE COURSES Patients receive oral temozolomide once daily on days 1-5 in courses 1-6 Patients also receive cilengitide IV on days 1 4 8 11 15 18 22 and 25 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cilengitide 3 Pre-defined study dose levels are defined as 500 1000 and 2000mg The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity If no MTD maximum tolerable dose is defined through three steps of the dose escalation process we will pursue the phase II safetyefficacy study with randomized treatment allocation Patients will be randomized into one of two pre-specified treatment dosage arms 500mg group or 2000mg group
PHASE II
Patients are stratified according to age 50 and under vs over 50 Karnofsky performance score 60-80 vs 90-100 and tumor status measurable vs nonmeasurable Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the lower dose as in safety run-in initiation and maintenance courses
ARM II Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the higher dose as in safety run-in initiation and maintenance courses
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 9-112 patients 9-18 for safety run-in and 94 47 per treatment arm for phase II will be accrued for this study within 15-37 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 |
|---|---|---|---|
| U01CA062475 | NIH | None | httpsreporternihgovquickSearchU01CA062475 |
| NABTT 0306 | None | None | None |
| CDR0000368451 | None | None | None |