Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326664
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2006-05-16
Brief Title:
AZD2171 in Treating Young Patients With Recurrent Progressive or Refractory Primary CNS Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical Trial of AZD2171 in Children With Recurrent or Progressive Central Nervous System CNS Tumors
Status:
COMPLETED
Status Verified Date:
2016-03
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 AZD2171 in treating young patients with recurrent progressive or refractory primary CNS tumors AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of AZD2171 in pediatric patients with recurrent progressive or refractory primary CNS tumors
II Describe the toxicity profile and dose-limiting toxicities of AZD2171 in these patients
SECONDARY OBJECTIVES
I Characterize inter-patient variability in the pharmacokinetics of AZD2171 in these patients
II Describe changes in circulating endothelial cells CECs and circulating endothelial cell precursors CEPs in patients treated with AZD2171 at different dose levels
III Correlate changes in CECs CEPs plasma serum and urine levels of proteins with angiogenesis including vascular endothelial growth factor VEGF and VEGF receptor in patients treated with AZD2171 at different dose levels
IV Correlate changes in CECs CEPs and angiogenic modulators with changes in magnetic resonance MR perfusion
V Obtain preliminary evidence of biologic activity of AZD2171 by evaluating alterations in tissue perfusion tumor blood flow and metabolic activity using MR perfusion and diffusion imaging and positron-emission tomography and correlating these findings with changes in tumor size by standard MRI
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent enzyme-inducing anticonvulsant drugs yes vs no
Patients receive oral AZD2171 once daily on days 1-28 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity
For each stratum cohorts of 2-6 patients receive escalating doses of AZD2171 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients experience dose-limiting toxicity Once the MTD is determined an additional 6 patients per stratum are enrolled and treated at the MTD
After completion of study patients are followed at 30 days
I Determine the maximum tolerated dose of AZD2171 in pediatric patients with recurrent progressive or refractory primary CNS tumors
II Describe the toxicity profile and dose-limiting toxicities of AZD2171 in these patients
SECONDARY OBJECTIVES
I Characterize inter-patient variability in the pharmacokinetics of AZD2171 in these patients
II Describe changes in circulating endothelial cells CECs and circulating endothelial cell precursors CEPs in patients treated with AZD2171 at different dose levels
III Correlate changes in CECs CEPs plasma serum and urine levels of proteins with angiogenesis including vascular endothelial growth factor VEGF and VEGF receptor in patients treated with AZD2171 at different dose levels
IV Correlate changes in CECs CEPs and angiogenic modulators with changes in magnetic resonance MR perfusion
V Obtain preliminary evidence of biologic activity of AZD2171 by evaluating alterations in tissue perfusion tumor blood flow and metabolic activity using MR perfusion and diffusion imaging and positron-emission tomography and correlating these findings with changes in tumor size by standard MRI
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent enzyme-inducing anticonvulsant drugs yes vs no
Patients receive oral AZD2171 once daily on days 1-28 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity
For each stratum cohorts of 2-6 patients receive escalating doses of AZD2171 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 25 of patients experience dose-limiting toxicity Once the MTD is determined an additional 6 patients per stratum are enrolled and treated at the MTD
After completion of study patients are followed at 30 days
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 |
|---|---|---|---|
| NCI-2009-00709 | REGISTRY | None | None |
| CDR0000476579 | None | None | None |
| PBTC-020 | None | None | None |
| PBTC-020 | OTHER | None | None |
| PBTC-020 | OTHER | None | None |
| U01CA081457 | NIH | CTEP | httpsreporternihgovquickSearchU01CA081457 |