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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

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