Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085111
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-06-10
Brief Title:
Bevacizumab in Treating Young Patients With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Bevacizumab in Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 bevacizumab in treating young patients with refractory solid tumors Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximum tolerable dose MTD of bevacizumab by dose escalation to a maximum of 15mgkg even if MTD is not reached administered as an intravenous infusion every 2 weeks to children with refractory solid tumors
II To determine the dose-limiting toxicities DLT and other toxicities of bevacizumab given on this schedule
III To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study
II To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF and parallel angiogenic markers V-CAM-1 ICAM-1 bFGF and TSP-1 at baseline and at time points post therapy
III To explore the biologic effect of bevacizumab on circulating endothelial cells CECs and circulating endothelial cell precursors CECPs
IV To determine in archival tumor tissue the expression of VEGF by immunohistochemistry andor real time PCR
OUTLINE This is a dose-escalation multicenter study
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bevacizumab 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 To estimate the maximum tolerable dose MTD of bevacizumab by dose escalation to a maximum of 15mgkg even if MTD is not reached administered as an intravenous infusion every 2 weeks to children with refractory solid tumors
II To determine the dose-limiting toxicities DLT and other toxicities of bevacizumab given on this schedule
III To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study
II To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF and parallel angiogenic markers V-CAM-1 ICAM-1 bFGF and TSP-1 at baseline and at time points post therapy
III To explore the biologic effect of bevacizumab on circulating endothelial cells CECs and circulating endothelial cell precursors CECPs
IV To determine in archival tumor tissue the expression of VEGF by immunohistochemistry andor real time PCR
OUTLINE This is a dose-escalation multicenter study
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bevacizumab 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 |
|---|---|---|---|
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0314 | None | None | None |
| COG-ADVL0314 | None | None | None |
| CDR0000367299 | None | None | None |
| NCI-04-C-0148 | None | None | None |