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View Clinical Trial (Medical Research Study)
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Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma - NCT00423735-54601 (Clinical Trial 105970)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy105970.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme or gliosarcoma
- Pre-therapy tumor tissue available
- Meets 1 of the following criteria:
- Patients accrued to stage 1 (closed to accrual as of 4/14/2009) or stage 1B
(opened to accrual as of 4/14/2009) must have tumors overexpressing at least 2
known dasatinib targets (i.e., SRC, KIT, PDGFR, or EPHA2)
- Patients accrued to stage 2 (closed as of 4/14/2009) do not require
overexpression of SRC, KIT, PDGFR, or EPHA2
- Prior treatment with radiotherapy and temozolomide required
- Radiographic evidence of tumor progression by MRI or CT scan
- Must be on stable or decreasing doses of corticosteroids for at least 5 days
before baseline MRI or CT scan
- Measurable disease is not required in patients who recently underwent resection
provided the following conditions are met as applicable:
- Progression of disease necessitated surgery
- Polifeprosan 20 with carmustine implants (Gliadel wafers®) were not placed
during the most recent surgery
- Neither convection-enhanced delivery nor catheters for infusion of chemotherapy
were used during the most recent surgery
- Radioactive seeds were not placed during the most recent surgery
- The histology of the most recent surgery documented
recurrent/persistent/progressive malignant glioma
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,000 cells/mm³
- Platelet count ≥ 75,000 cells/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- WBC ≥ 3,000 cells/mm³
- Absolute lymphocyte count ≥ 500 cells/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 3 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior invasive malignancy except for nonmelanomatous skin cancer unless
disease-free for a minimum of 3 years
- No severe active comorbidity, defined as any of the following:
- Clinically significant cardiovascular disease, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization
within the past 6 months
- Transmural myocardial infarction or ventricular tachyarrhythmia within the
past 6 months
- Prolonged QTc > 480 msec (by Fridericia's correction)
- Ejection fraction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization
- No known AIDS
- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to dasatinib
- No condition that impairs the ability to swallow or retain tablets, such as the
following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery for recurrent/progressive disease allowed
- Recovered from prior surgery
- More than 4 weeks since prior radiotherapy and recovered
- More than 2 weeks since prior temozolomide and recovered
- More than 2 weeks since prior and no concurrent enzyme-inducing antiepileptic drugs
- No prior therapy except radiotherapy and temozolomide
- No prior stereotactic radiosurgery or brachytherapy
- At least 7 days since prior and no concurrent potent inhibitors of CYP3A4
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- At least 7 days since prior and no concurrent antithrombotic and/or antiplatelet
agents (e.g., warfarin, heparin, low molecular weight heparin, acetylsalicyclic acid,
clopidogrel, ticlopidine, or Aggrenox)
- No locally acting antacids (Maalox, Mylanta) within 2 hours before or after study
treatment
- No concurrent systemic antacids, including H2 receptor antagonist or proton pump
inhibitors
- No concurrent ibuprofen or NSAIDs
- No concurrent large quantities of grapefruit or its juice
- No concurrent potent inducers of CYP3A4
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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