Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077155
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-02-10
Brief Title:
Cilengitide EMD 121974 in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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 phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma Cilengitide EMD 121974 may stop the growth of cancer cells by stopping blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity maximum feasible dose and recommended phase II dose of cilengitide EMD 121974 in patients with advanced solid tumors or lymphoma
II Determine the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this drug in these patients II Determine the antineoplastic activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive cilengitide EMD 121974 IV continuously on weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
I Determine the dose-limiting toxicity maximum feasible dose and recommended phase II dose of cilengitide EMD 121974 in patients with advanced solid tumors or lymphoma
II Determine the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this drug in these patients II Determine the antineoplastic activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive cilengitide EMD 121974 IV continuously on weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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 2 of 3 or 2 of 6 patients experience dose-limiting 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 |
|---|---|---|---|
| UCCRC-12774A | None | None | None |
| CDR0000349535 | REGISTRY | PDQ Physician Data Query | None |