Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural
cavity may improve the body's ability to fight cancer.
PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating
patients who have malignant pleural mesothelioma or malignant pleural effusions.
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.
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