Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063973
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2003-07-08
Brief Title:
Cilengitide in Treating Children With Refractory Primary Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Cilengitide EMD 121974 in Children With Refractory Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-09
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 cilengitide in treating children with recurrent progressive or refractory primary CNS tumors Cilengitide may slow the growth of brain cancer cells by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To describe the acute and dose-limiting toxicities DLT and define the maximum tolerated dose MTD of cilengitide EMD 121974 when administered to children and adolescents with refractory primary brain tumors
SECONDARY OBJECTIVES
I To obtain preliminary evidence of biologic activity by determining alterations in tissue perfusion tumor blood flow and metabolic activity using MR perfusion PET and MRS and correlating these findings with changes in tumor size by volumetric MRI
II To characterize inter- and intra-patient variability in the pharmacokinetics of cilengitide and to estimate cilengitide renal clearance in this patient population
III To characterize the pharmacogenetic polymorphisms in drug transporters eg MRP4 BCRP and relate to cilengitide disposition
IV To evaluate changes in circulating endothelial cells CECs and circulating endothelial precursors CEPs in patients treated with cilengitide and to investigate the correlation between changes in CECs and CEPs plasma serum and urine angiogenic protein levels such as VEGF and clinical outcome
V To obtain preliminary information about the efficacy of cilengitide in this patient population
OUTLINE This is a dose-escalation multicenter study
Patients receive cilengitide EMD 121974 IV over 1 hour twice weekly Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cilengitide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients are expected to experience dose-limiting toxicity Once the MTD is determined 6 additional patients are accrued and treated at that dose level for a total of 12 patients at the MTD
Patients receiving treatment are followed weekly for the first three months then monthly for one year or 13 courses of treatment Patients discontinuing treatment will be followed for resolution of all adverse events occurring while on treatment andor within 30 days of the last administration of study drug
Patients will be followed for the shortest of 1 three months after the last protocol based treatment or 2 the date other therapy is initiated
I To describe the acute and dose-limiting toxicities DLT and define the maximum tolerated dose MTD of cilengitide EMD 121974 when administered to children and adolescents with refractory primary brain tumors
SECONDARY OBJECTIVES
I To obtain preliminary evidence of biologic activity by determining alterations in tissue perfusion tumor blood flow and metabolic activity using MR perfusion PET and MRS and correlating these findings with changes in tumor size by volumetric MRI
II To characterize inter- and intra-patient variability in the pharmacokinetics of cilengitide and to estimate cilengitide renal clearance in this patient population
III To characterize the pharmacogenetic polymorphisms in drug transporters eg MRP4 BCRP and relate to cilengitide disposition
IV To evaluate changes in circulating endothelial cells CECs and circulating endothelial precursors CEPs in patients treated with cilengitide and to investigate the correlation between changes in CECs and CEPs plasma serum and urine angiogenic protein levels such as VEGF and clinical outcome
V To obtain preliminary information about the efficacy of cilengitide in this patient population
OUTLINE This is a dose-escalation multicenter study
Patients receive cilengitide EMD 121974 IV over 1 hour twice weekly Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cilengitide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients are expected to experience dose-limiting toxicity Once the MTD is determined 6 additional patients are accrued and treated at that dose level for a total of 12 patients at the MTD
Patients receiving treatment are followed weekly for the first three months then monthly for one year or 13 courses of treatment Patients discontinuing treatment will be followed for resolution of all adverse events occurring while on treatment andor within 30 days of the last administration of study drug
Patients will be followed for the shortest of 1 three months after the last protocol based treatment or 2 the date other therapy is initiated
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 |
|---|---|---|---|
| U01CA081457 | NIH | CTEP | httpsreporternihgovquickSearchU01CA081457 |
| NCI-2012-03175 | REGISTRY | None | None |
| CDR653715 | None | None | None |
| PBTC-012 | OTHER | None | None |
| PBTC-012 | OTHER | None | None |