Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma
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.
Brain and Central Nervous System Tumors
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma|
- Treatment success (complete or partial response or a progression-free survival at 6 months) [ Designated as safety issue: No ]
- Objective response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Progression-free survival at 6 months [ Designated as safety issue: No ]
- Overall survival at 6 and 12 months [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424060
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|