NCT00424060

Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma

Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	sagopilone
GENETIC	fluorescence in situ hybridization
GENETIC	gene expression analysis
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-08-01
• First posted: 2007-01-18
• Last updated: 2012-09-24

Locations

1 site across 1 country: Switzerland