Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma
|ClinicalTrials.gov Identifier: NCT00424060|
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: sagopilone Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
- Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||August 2007|
- Treatment success (complete or partial response or a progression-free survival at 6 months)
- Objective response
- Duration of response
- Progression-free survival at 6 months
- Overall survival at 6 and 12 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424060
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|