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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00423735 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: dasatinib Genetic: gene expression analysis Genetic: mutation analysis Other: immunohistochemistry staining method Other: immunologic technique Other: liquid chromatography Other: mass spectrometry Other: pharmacological study Procedure: biopsy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme |
| Estimated Enrollment: | 113 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme or gliosarcoma
Meets 1 of the following criteria:
Radiographic evidence of tumor progression by MRI or CT scan
Measurable disease is not required in patients who recently underwent resection provided the following conditions are met as applicable:
PATIENT CHARACTERISTICS:
No severe active comorbidity, defined as any of the following:
Clinically significant cardiovascular disease, including any of the following:
No condition that impairs the ability to swallow or retain tablets, such as the following:
PRIOR CONCURRENT THERAPY:
Prior surgery for recurrent/progressive disease allowed
Contacts and Locations
Show 117 Study Locations| Study Chair: | Andrew B. Lassman, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00423735 History of Changes |
| Other Study ID Numbers: | CDR0000526070, RTOG-0627 |
| Study First Received: | January 16, 2007 |
| Last Updated: | August 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
adult giant cell glioblastoma recurrent adult brain tumor adult glioblastoma adult gliosarcoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |