Advertisement

Topics

Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

2014-08-27 03:40:39 | BioPortfolio

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.

Description

OBJECTIVES:

Primary

- Determine the therapeutic efficacy of dasatinib, in terms of 6-month progression-free survival, in all patients (i.e., stage 1B [closed to accrual as of 4/14/2009] and stage 2 [closed to accrual as of 4/14/2009] combined) with recurrent/progressive glioblastoma multiforme or gliosarcoma.

Secondary

- Determine the therapeutic efficacy of this drug, in terms of a hybrid endpoint of 6-month progression-free survival or objective response (complete or partial) rate, in patients in stage 1B (closed to accrual as of 4/14/2009).

- Determine overall survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine radiographic response rate in patients treated with this regimen.

- Determine progression-free survival of patients treated with this regimen.

- Explore molecular correlates of clinical outcome in patients treated with this regimen.

- Explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE: This a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tumor biopsies are collected at baseline and may be collected after the completion of study treatment. Immunohistochemistry and western blot analysis of baseline tissue are performed to identify molecular signatures that predict glioblastoma sensitivity to dasatinib. The presence of the targets (SRC, platelet-derived growth factor receptor [PDGFR] beta, EPHA2, and KIT) and their activated (phosphorylated) forms are examined and correlated with clinical outcome. Specimens are also examined for mutations that increase dasatinib sensitivity. Pharmacokinetic analysis will also be performed to determine plasma concentrations of dasatinib via liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS).

After the completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 113 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

dasatinib, gene expression analysis, mutation analysis, immunohistochemistry staining method, immunologic technique, liquid chromatography, mass spectrometry, pharmacological study, biopsy

Location

Arizona Oncology Services Foundation
Phoenix
Arizona
United States
85013

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:39-0400

Clinical Trials [3331 Associated Clinical Trials listed on BioPortfolio]

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treati...

Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. PURPOSE: This phase II trial is studying dasatinib to see how well it work...

Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treati...

Studying Gene Expression and Location in Samples From Patients With Brain Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors. PURPOSE: This re...

Biomarkers in Tumor Samples From Younger Patients With Neuroblastoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cance...

PubMed Articles [43107 Associated PubMed Articles listed on BioPortfolio]

p-STAT3 in luminal breast cancer: Integrated RNA-protein pooled analysis and results from the BIG 2-98 phase III trial.

In the present study, in order to investigate the role of signal transducer and activator of transcription 3 (STAT3) in estrogen receptor (ER)-positive breast cancer prognosis, we evaluated the phos...

High resolution melting for F9 gene mutation analysis in patients with haemophilia B.

Since 2001, we have used conformation sensitive gel electrophoresis (CSGE) as our first choice for F9 gene mutation screening, leading to the identification of about 300 mutations causing haemophilia ...

GAIT: Gene expression Analysis for Interval Time.

Despite the potential usefulness, the association analysis of gene expression with interval times of two events has been hampered because the occurrence of events can be censored and the conventional ...

Prognostic relevance of tripartite motif containing 24 expression in colorectal cancer.

Colorectal cancer is one of the most frequent malignancies in the world. Tripartite motif containing 24 (TRIM24) is a member of the TRIM protein family and a coregulator for multiple nuclear receptors...

X-Linked Hypohidrotic Ectodermal Dysplasia: New Features and a Novel EDA Gene Mutation.

We described a 5-year-old male with hypodontia, hypohidrosis, and facial dysmorphisms characterized by a depressed nasal bridge, maxillary hypoplasia, and protuberant lips. Chromosomal analysis reveal...

Medical and Biotech [MESH] Definitions

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.

A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

Hybridization of a nucleic acid sample to a very large set of oligonucleotide probes, which are attached to a solid support, to determine sequence or to detect variations in a gene sequence or expression or for gene mapping.

The use of techniques that produce a functional MUTATION or an effect on GENE EXPRESSION of a specific gene of interest in order to identify the role or activity of the gene product of that gene.

Meta-analysis of randomized trials in which estimates of comparative treatment effects are visualized and interpreted from a network of interventions that may or may not have been evaluated directly against each other. Common considerations in network meta-analysis include conceptual and statistical heterogeneity and incoherence.

More From BioPortfolio on "Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial