Finding studies
Finding studies
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Lead
Abramson Cancer Center at Penn Medicine
With
OBJECTIVES: * Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions. * Determine the maximum tolerated dose of this drug in these patients. * Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug. * Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug. * Determine, preliminarily, tumor response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive BG00001 via an intrapleural catheter on day 1. Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and then every 6 months for 15 years. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
