Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006093
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-08-03
Brief Title:
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
Status:
COMPLETED
Status Verified Date:
2003-04
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 EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase III trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma
PURPOSE Phase III trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma
Determine the 6-month progression-free survival clinical response rate duration of progression-free survival and overall survival in patients treated with this drug
Determine the effects of this drug on tumor perfusion measured with magnetic resonance perfusion scan and markers for angiogenesis in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive EMD 121974 IV over 1 hour twice weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 6 patients will be accrued for phase I of this study within 2-3 months A total of 23-38 patients will be accrued for phase II of this study within 5-10 months
Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma
Determine the 6-month progression-free survival clinical response rate duration of progression-free survival and overall survival in patients treated with this drug
Determine the effects of this drug on tumor perfusion measured with magnetic resonance perfusion scan and markers for angiogenesis in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive EMD 121974 IV over 1 hour twice weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 6 patients will be accrued for phase I of this study within 2-3 months A total of 23-38 patients will be accrued for phase II of this study within 5-10 months
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 |
|---|---|---|---|
| NABTT-9911 | None | None | None |
| JHOC-NABTT-9911 | None | None | None |