Status and phase
Conditions
Treatments
About
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.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed diagnoses:
Malignant pleural mesothelioma
Metastatic malignancy to the pleural space
Originating from 1 of the following sites:
Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
Measurable or evaluable disease
Pleural space involved with tumor accessible for pleural catheter insertion
No malignant pleural effusions secondary to lymphoma or sarcoma
No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
No known brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal