Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of ZK 219477 in 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.
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.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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