Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma

Exclusion Criteria

• •Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
• •Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
• •Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
• •* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• •* History or presence of serious uncontrolled ventricular arrhythmias
• •* Clinically significant resting bradycardia
• •* Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (2-D) echocardiogram (ECHO) \< 50% or lower limit of normal (whichever is higher) or multi gated acquisition scan (MUGA) \< 45% or lower limit of normal (whichever is higher)
• •* Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), and transient ischemic attack (TIA)
• •* Uncontrolled hypertension defined by a systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg, with or without anti-hypertensive medication(s)
• •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• •Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• •Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
• •Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
• •Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ≤ 14 days prior to starting study treatment
• •Fertile males not willing to use contraception, as stated above
• •Patients who are currently receiving full dose anticoagulation treatment with therapeutic doses of warfarin or anti-platelet therapy (e.g., Plavix \[clopidogrel bisulfate\]); treatment with locally accepted low molecular weight heparin and low dose of acetylsalicylic acid (i.e., 81mg or 100 mg daily) to prevent cardiovascular events or strokes is allowed
• •Patients unwilling or unable to comply with the protocol
• •Any significant hemorrhage defined as \> 1 cm diameter of blood seen on the MRI or CT scan. If \> 1 cm of acute blood is detected, the patient will be ineligible for this trial.