Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed malignant glioblastoma multiforme
• Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy
• Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm
• Paraffin embedded tumor sample available
• Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study
• * Patients in phase II of the study may or may not be receiving EIAEDs
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin ≤ upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Renal
• Creatinine ≤ 1.5 times ULN
• Cardiovascular
• LVEF ≥ 50% by echocardiogram or MUGA
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No active cardiomyopathy
• No cardiac arrhythmia
• No uncontrolled hypertension
• Pulmonary
• No pulmonary disease requiring oxygen
• Neurologic
• No preexisting peripheral neuropathy ≥ grade 3
• No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent
• Gastrointestinal
• No upper gastrointestinal or other conditions that would preclude compliance with oral medication
• No active peptic ulcer disease
• Other
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor
• No immune deficiency
• No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent
• No other serious illness or medical condition that would preclude study participation
• No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib
• No active uncontrolled or serious infection
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors
• * Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia)
• Chemotherapy
• See Disease Characteristics
• No prior chemotherapy for recurrent disease
• No more than one prior chemotherapy regimen in the adjuvant setting
• * At least 6 months since prior adjuvant chemotherapy
• Endocrine therapy
• Concurrent steroids allowed provided the dose is stable for at least 14 days before study entry
• Radiotherapy
• See Disease Characteristics
• At least 6 weeks since prior radiotherapy
• Surgery
• At least 2 weeks since prior major surgery
• Other
• H2 blockers and proton pump inhibitors allowed, unless they are CYP3A4 inducers or inhibitors
• At least 7 days since prior and no concurrent administration of any of the following CYP3A4 inhibitors:
• * Clarithromycin
• * Erythromycin
• * Troleandomycin
• * Telithromycin
• * Ciprofloxacin
• * Norfloxacin
• * Itraconazole
• * Ketoconazole
• * Voriconazole
• * Fluconazole (≤150 mg/day allowed)
• * Nefazodone
• * Fluovoxamine
• * Delavirdine
• * Nelfinavir
• * Amprenavir
• * Ritonavir
• * Indinavir
• * Saquinavir
• * Lopinavir
• * Verapamil
• * Diltiazem
• * Aprepitant
• * Grapefruit or grapefruit juice
• * Bitter orange
• At least 14 days since prior and no concurrent administration of any of the following CYP3A4 inducers:
• * Rifampin
• * Rifabutin
• * Rifapentine
• * Efavirenz
• * Nevirapine
• * Hypericum perforatum (St. John's wort)
• * Modafinil
• At least 6 months since prior and no concurrent administration of amiodarone
• Antacids (e.g., mylanta, maalox, tums, rennies) must be administered ≥ 1 hour before and ≥ 1 hour after study drug
• At least 2 days since prior and no concurrent cimetidine
• No other concurrent anti-cancer agents
• No other concurrent investigational therapy