Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00423735
Eligibility Criteria:
Inclusion Criteria:
* 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
* Radioactive seeds were not placed during the most recent surgery
* The histology of the most recent surgery documented recurrent/persistent/progressive malignant glioma
* Women of childbearing potential must have a negative beta human chorionic gonadotropin (B HCG) pregnancy test =\< 3 days prior to registration
* Patient must sign study-specific informed consent prior to study entry
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00423735
Study Brief:
Protocol Section:
NCT00423735