Enzastaurin and Bevacizumab in Treating Patients With Recurrent Malignant Gliomas
Summary
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Enzastaurin and bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving enzastaurin together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving enzastaurin together with bevacizumab works in treating patients with recurrent malignant gliomas.
Description
OBJECTIVES:
Primary
- To evaluate the anti-glioma activity of enzastaurin hydrochloride when given together with bevacizumab in patients with recurrent malignant gliomas.
- To obtain information regarding the safety of this regimen in these patients.
Secondary
- To obtain exploratory data regarding the relationship between clinical outcome and GSK3-b activation in peripheral blood mononuclear cells and overall tumor-associated GSK protein levels as assessed by IHC from paraffin sections in patients treated with this regimen.
- To assess the impact of this regimen on health-related quality of life of these patients.
OUTLINE: Patients receive oral enzastaurin hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete the Functional Assessment of Cancer Therapy-Brain questionnaire before each course of treatment. Peripheral blood mononuclear cells are collected periodically to assay phospho-GSK levels.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Brain and Central Nervous System Tumors
Intervention
bevacizumab, enzastaurin hydrochloride, protein expression analysis, immunohistochemistry staining method, quality-of-life assessment
Location
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00559923
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Molecular Diagnostic Techniques
MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.
Neurocytoma
A benign brain tumor composed of neural elements which most often arise from the SEPTUM PELLUCIDUM and the walls of the lateral ventricles. Immunohistochemistry and electron microscopy evaluations may reveal expression of neuron specific enolase and synaptophysin and cells containing microtubuli, neurosecretory granules, and presynaptic vesicles. (From Acta Med Port 1994 Feb;7(2):113-9)
Sequence Analysis, Protein
A process that includes the determination of an amino acid sequence of a protein (or peptide, oligopeptide or peptide fragment) and the information analysis of the sequence.
Inclusion Bodies, Viral
An area showing altered staining behavior in the nucleus or cytoplasm of a virus-infected cell. Some inclusion bodies represent "virus factories" in which viral nucleic acid or protein is being synthesized; others are merely artifacts of fixation and staining. One example, Negri bodies, are found in the cytoplasm or processes of nerve cells in animals that have died from rabies.
Peptide Mapping
Analysis of PEPTIDES that are generated from the digestion or fragmentation of a protein or mixture of PROTEINS, by ELECTROPHORESIS; CHROMATOGRAPHY; or MASS SPECTROMETRY. The resulting peptide fingerprints are analyzed for a variety of purposes including the identification of the proteins in a sample, GENETIC POLYMORPHISMS, patterns of gene expression, and patterns diagnostic for diseases.
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