Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326872
Status:
TERMINATED
Last Update Posted:
2017-08-18
First Post:
2006-05-16
Brief Title:
AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma andor Neurofibroma Near the Spine
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of AZD2171 in Adult Patients With Neurofibromatosis Type 1 and Extensive Plexiform and Paraspinal Neurofibromas
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to slow accrual prior to interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma andor neurofibroma near the spine 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 Assess the efficacy of AZD2171 in terms of volume change in target tumors by 3-dimensional magnetic resonance imaging 3D MRI
II Describe and define the toxicities of AZD2171 in these patients
SECONDARY OBJECTIVES
I Assess the value of 3D MRI data analysis in evaluating plexiform or paraspinal neurofibromas compared to conventional 2-dimensional MRI data analysis
II Assess the value of delayed contrast-enhanced MRI DCE-MRI in determining changes in vascularity of neurofibromas before and during treatment III Assess the quality of life of patients treated with AZD2171 IV Evaluate the effect of AZD2171 on biological changes of human neurofibroma by comparing pre- and post-treatment specimens from patients involved in this trial or alternatively by evaluating the effect of AZD2171 on human tumor grafts in experimental animals
V Evaluate relevant pharmacodynamic markers circulating endothelial cells CECs and vascular endothelial growth factor-2 VEGF2 levels and pharmacogenetics analyses variation in kdrflk-1 and other genes in response to AZD2171
OUTLINE This is a multicenter study Patients are stratified according to tumor location peripheral vs paraspinal plexiform neurofibroma Patients receive oral AZD2171 once daily on days 1-28
Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline prior to course 2 prior to course 4 and every 6 courses thereafter
I Assess the efficacy of AZD2171 in terms of volume change in target tumors by 3-dimensional magnetic resonance imaging 3D MRI
II Describe and define the toxicities of AZD2171 in these patients
SECONDARY OBJECTIVES
I Assess the value of 3D MRI data analysis in evaluating plexiform or paraspinal neurofibromas compared to conventional 2-dimensional MRI data analysis
II Assess the value of delayed contrast-enhanced MRI DCE-MRI in determining changes in vascularity of neurofibromas before and during treatment III Assess the quality of life of patients treated with AZD2171 IV Evaluate the effect of AZD2171 on biological changes of human neurofibroma by comparing pre- and post-treatment specimens from patients involved in this trial or alternatively by evaluating the effect of AZD2171 on human tumor grafts in experimental animals
V Evaluate relevant pharmacodynamic markers circulating endothelial cells CECs and vascular endothelial growth factor-2 VEGF2 levels and pharmacogenetics analyses variation in kdrflk-1 and other genes in response to AZD2171
OUTLINE This is a multicenter study Patients are stratified according to tumor location peripheral vs paraspinal plexiform neurofibroma Patients receive oral AZD2171 once daily on days 1-28
Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline prior to course 2 prior to course 4 and every 6 courses thereafter
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 |
|---|---|---|---|
| P30CA015083 | NIH | CTEP | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2009-00128 | REGISTRY | None | None |
| MC047F | None | None | None |
| CDR0000475761 | None | None | None |
| MC047F | OTHER | None | None |
| 7133 | OTHER | None | None |
| N01CM17104 | NIH | None | None |
| N01CM62205 | NIH | None | None |