Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma

This is an interventional treatment trial for Adult Brain Tumor Read More

Criteria:

• Histologically confirmed glioblastoma:

  • Progressive or recurrent disease after prior radiotherapy (with or without chemotherapy)
  • Patients with a previous low-grade glioma that progressed after prior radiotherapy (with or without chemotherapy) and are found to have glioblastoma by biopsy are eligible
• Measurable disease, defined as contrast-enhancing progressive or recurrent glioblastoma by MRI or CT imaging within the past 2 weeks
• Must be maintained on a stable corticosteroid regimen from the time of baseline scan to the start of study treatment

• Feasibility study only:

  • Planning to undergo surgical resection or biopsy
  • Stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects allowed
  • Corticosteroids must be tapered to the lowest required steroid dose and patient must be maintained on a stable dose after surgery or biopsy
• Karnofsky performance status 60-100%
• Absolute neutrophil count >= 1,500/mm^3
• Hemoglobin >= 10 mg/dL
• Bilirubin =< 1.5 mg/dL
• AST and ALT =< 4 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
• Mini Mental State Exam score >= 15
• Mean QTc =< 500 msec (with Bazett's correction) by screening electrocardiogram
• LVEF >= 40%
• No history of familial long QT syndrome
• No myocardial infarction within the past 6 months
• No severe uncontrolled ventricular arrhythmias
• No uncontrolled angina
• No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• No ongoing vomiting or nausea >= grade 2
• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous alimentation
• No active peptic ulcer disease
• No other condition that would impair ability to swallow pills or absorb oral medications
• No muscular dystrophy
• No myasthenia gravis
• No other known or suspected primary muscular or neuromuscular disease
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib (e.g., erlotinib hydrochloride, gefetinib, or doxazosin mesylate)
• Patients who developed an acneiform/maculopustular rash while receiving either gefitinib or erlotinib hydrochloride are eligible unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome
• No ongoing or active infections
• No psychiatric illness or social situations that would preclude study compliance
• No other serious infection or medical illness
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• No other uncontrolled illness
• No other malignancy within the past 5 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
• Recovered from prior therapy
• At least 3 months since prior radiotherapy
• No prior surgical procedures affecting absorption
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No concurrent agent that would cause QTc prolongation
• No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
• At least 10 days since prior and no concurrent anticonvulsant drugs that induce hepatic metabolic enzymes (e.g., primidone, oxcarbazepine, phenytoin, carbamazepine, or phenobarbital)
• No prior treatment with small molecule inhibitors of platelet-derived growth factor receptor (e.g., sunitinib malate, sorafenib, or imatinib mesylate)
• Platelet count >= 100,000/mm^3
• No New York Heart Association class III or IV heart failure
• Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60mL/min