Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm

In brief

This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00423735

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2007-01-24

Expected to finish

2018-09-04

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis
• The patient must consent to submission of tissue for central pathology review
• Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study
• All patients must consent to molecular analysis of pre-dasatinib tumor tissue
• Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase [SRC], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog [KIT], platelet-derived growth factor receptor [PDGFR], or ephrin type-A receptor 2 [EPHA2])
• Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2
• History and physical examination, including height and weight, within 10 days prior to registration on study
• Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study
• Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning
• Karnofsky performance status >= 60
• Absolute neutrophil count (ANC) >= 1,000 cells/mm\^3
• Platelets >= 75,000 cells/mm\^3
• Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
• Leukocytes >= 3,000 cells/mm\^3
• Absolute lymphocyte count (ALC) >= 500 cells/mm\^3
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional upper limit of normal
• Creatinine =< 3 X institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• All patients must have undergone prior treatment with radiotherapy and temozolomide; no other prior treatments are allowed
• There must be unequivocal radiographic evidence for tumor progression by MRI or CT scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period of protocol treatment for tumor measurement; patients must be on a stable or decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is performed
• Patients having undergone recent surgery for recurrent/progressive disease are eligible as long as they have recovered from the effects of surgery; patients who recently underwent resection without measurable disease post-operatively are also eligible
• Measurable disease is not required for eligibility in patients who recently underwent resection as long as the following conditions are met as applicable:
• Progression of disease led to the surgery
• 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

You may not qualify if…

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or failure to recover from adverse events of either radiotherapy or temozolomide
• Patients may not be receiving any other investigational agents
• Severe, active comorbidity, defined as follows:
• Any clinically significant cardiovascular disease including 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 corrected QT interval (QTc) > 480 msec (Fridericia correction)
• Ejection fraction less than institutional normal
• Major conduction abnormality (unless a cardiac pacemaker is present)
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; breastfeeding should be discontinued if the mother is treated with dasatinib
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib
• Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
• Patients must not be taking hepatic enzyme inducing antiepileptic drugs (EIAEDs); if patients were previously on EIAEDs that have been discontinued, patients must have been off EIAEDs for >= 2 weeks prior to initiation of dasatinib
• Patients who require antacids should use short-acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose
• Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox)
• Use of ibuprofen or non-steroidal anti-inflammatory drugs (NSAIDs)
• Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
• Prior treatment with stereotactic radiosurgery (including Gamma-Knife, Cyberknife, or other variants) or brachytherapy

Where it is running

• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Mercy General Hospital Radiation Oncology Center — Sacramento, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Vacaville — Vacaville, California, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Southside Cancer Center — Jacksonville, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Florida Cancer Center Beaches — Jacksonville Beach, Florida, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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