Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT00424060
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2007-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
Study Overview
Official Title:
Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma.
PURPOSE: This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma.
Detailed Description:
OBJECTIVES:
Primary
* Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma.
Secondary
* Determine the safety profile, mechanism of action, and pharmacokinetics of this drug in these patients.
* Gather information about the biological characteristics of the patients' tumor that may provide information on response or resistance to this drug.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive epothilone ZK-219477 IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline for biomarker analysis and for comparison of genetic alterations in tumor tissue with germline DNA. Blood samples are also collected periodically during course 1 for pharmacokinetic studies. Tumor tissue obtained at diagnosis, and possibly recurrence, is used for immunohistochemical analyses for biomarkers. Fluorescent in situ hybridization (FISH) is used to detect genetic alterations and gene expression.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Primary
* Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma.
Secondary
* Determine the safety profile, mechanism of action, and pharmacokinetics of this drug in these patients.
* Gather information about the biological characteristics of the patients' tumor that may provide information on response or resistance to this drug.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive epothilone ZK-219477 IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline for biomarker analysis and for comparison of genetic alterations in tumor tissue with germline DNA. Blood samples are also collected periodically during course 1 for pharmacokinetic studies. Tumor tissue obtained at diagnosis, and possibly recurrence, is used for immunohistochemical analyses for biomarkers. Fluorescent in situ hybridization (FISH) is used to detect genetic alterations and gene expression.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: