Trials / Completed
CompletedNCT00066404
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | recombinant adenovirus-hIFN-beta |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2006-01-01
- Completion
- 2006-01-01
- First posted
- 2003-08-07
- Last updated
- 2020-05-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00066404. Inclusion in this directory is not an endorsement.