Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066404
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2003-08-06
Brief Title:
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta IFN-ß Gene Transfer for Pleural Malignancies
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Using BG00001 to insert the gene for interferon-beta into a persons pleural cavity may improve the bodys 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
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 transferinterferon 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
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 transferinterferon 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC-01502 | None | None | None |