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Concentration and Activity of Lapatinib in Vestibular Schwannomas
Bu çalışma, vestibüler schwannom (vestibular schwannoma) adı verilen tümörü olan hastalarda Lapatinib ilacının tümör dokusundaki konsantrasyonunu ve aktivitesini incelemiştir. Çalışmaya, NF2 tanı kriterlerini karşılayan veya idiyopatik vestibüler schwannomu olan ve dört hafta içinde ameliyatı planlanan hastalar katılabilmiştir. Johns Hopkins Sidney Kimmel Comprehensive Cancer Center tarafından yürütülen çalışma Erken Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Meet diagnostic criteria for NF2 including presence of bilateral VS or idiopathic VS without evidence of genetic syndrome. * VS surgery determined clinically necessary by the treating physician and scheduled within 4 weeks. * Normal cardiac left ventricular ejection fraction (LVEF) by multiple-gated acquisition (MUGA) scan or transthoracic echocardiogram. * Karnofsky performance status 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). * Must have the following hematologic, renal and liver function: Absolute neutrophil count ≥ 1,000/mm³ (unsupported); platelet count ≥ 75,000/mm³ (unsupported); hemoglobin ≥ 8 g/dL (transfusion support allowed); Creatinine ≤ 1.5 times upper limit of normal (ULN) OR glomerular filtration rate ≥ 70 ml/min; Bilirubin ≤ 1.5 times ULN; ALT ≤ 2.5 times ULN. * Be able to provide written informed consent. * Any neurologic deficits must be stable for ≥ 1 week. * Be able to swallow tablets. * Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. * Suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinib. Exclusion Criteria: * Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. * Pregnant or breast-feeding. * Receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents, radiation or immunotherapy) within 4 weeks of the first dose of the study drug. * Concurrent or prior malignancy, other than curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Subjects who have been free of disease (any prior malignancy) for five years are eligible for this study. * Received cytochrome P450-inducing anticonvulsants (EIADs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) or similar agents (e.g., rifampin) or P450 inhibiting agents (Ketoconazole, Itraconazole, Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole) within 10 days prior to starting lapatinib. * Significant gastrointestinal disorder(s)(e.g., Crohn's disease, ulcerative colitis, extensive gastric resection). * Neurologic deficits that are rapidly progressing. * Known cardiac disease (either arrhythmia or congestive heart failure) requiring treatment.