Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor
Eligibility 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
Sites / Locations
- Tom Baker Cancer Centre - Calgary
- British Columbia Cancer Agency - Centre for the Southern Interior
- British Columbia Cancer Agency - Vancouver Cancer Centre
- Margaret and Charles Juravinski Cancer Centre
- Princess Margaret Hospital
- Centre Hospitalier de l'Universite de Montreal