Inclusion Criteria

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