Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089388
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2004-08-04
Brief Title:
Cilengitide in Treating Patients With Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
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 how well cilengitide works in treating patients with acute myeloid leukemia Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy
SECONDARY OBJECTIVES
I Determine overall survival of patients treated with this drug II Determine the safety and toxicity of this drug in these patients III Determine the biological activity of this drug in cells from these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks
Arm II Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks
In both arms courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity
I Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy
SECONDARY OBJECTIVES
I Determine overall survival of patients treated with this drug II Determine the safety and toxicity of this drug in these patients III Determine the biological activity of this drug in cells from these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks
Arm II Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks
In both arms courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity
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 |
|---|---|---|---|
| MDA-2003-1007 | None | None | None |
| CDR0000378310 | REGISTRY | PDQ Physician Data Query | None |