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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00424060 |
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 | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: epothilone ZK-219477 Procedure: fluorescence in situ hybridization Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Ixabepilone |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma |
Estimated Enrollment: | 35 |
Study Start Date: | December 2006 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma
Recurrent disease
PATIENT CHARACTERISTICS:
No ischemic heart disease within the past 12 months
PRIOR CONCURRENT THERAPY:
More than 3 months since prior surgery for recurrent primary brain tumor unless 1 of the following criteria are met:
No prior chemotherapy for recurrent glioblastoma
No concurrent enzyme-inducing antiepileptic drugs (EIAEDs)
Switzerland | |||||
Centre Hospitalier Universitaire Vaudois | |||||
Lausanne, Switzerland, CH-1011 |
European Organization for Research and Treatment of Cancer |
Study Chair: | Roger Stupp, MD | Centre Hospitalier Universitaire Vaudois |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Stupp R, Tosoni W, Taal W, et al.: Phase II trial of the epothilone analog sagopilone (ZK219477; ZK EPO) in patients with recurrent glioblastoma: initial report of the EORTC study 26061. [Abstract] J Clin Oncol 26 (Suppl 15): A-2015, 2008.
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Study ID Numbers: | CDR0000525507, EORTC-26061, EUDRACT-2006-001659-37, SPRI-EORTC-26061 |
First Received: | January 16, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00424060 |
Health Authority: | United States: Federal Government |
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