Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
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|ClinicalTrials.gov Identifier: NCT00066404|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : May 13, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: recombinant adenovirus-hIFN-beta||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066404
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Daniel H. Sterman, MD||Abramson Cancer Center of the University of Pennsylvania|