Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004033
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-12-10
Brief Title:
Liposomal-Cisplatin Analogue L-NDDP in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog L-NDDP Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2011-03
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 Patient abstract not available
PURPOSE Patient abstract not available
PURPOSE Patient abstract not available
Detailed Description:
OBJECTIVES I Determine the antitumor efficacy of a liposomal-cisplatin analogue L-NDDP administered into the pleural space in patients with malignant pleural mesothelioma II Determine the time to progression and overall survival in this patient population III Evaluate the quantitative and qualitative toxicity of intrapleural L-NDDP
OUTLINE All patients undergo a thoracoscopy under general anesthesia The thoracoscope is removed and any collected fluid is drained from the chest cavity The first treatment with liposomal-cisplatin analogue L-NDDP is administered at this time into the intrapleural space over a 10 minute period Subsequent 10 minute intrapleural infusions of L-NDDP through a percutaneous catheter are administered every 3 weeks Treatment continues unless unacceptable toxic effects or disease progression occurs Antitumor activity is assessed 2 months after the second course of therapy and every 2 months thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 25 years
OUTLINE All patients undergo a thoracoscopy under general anesthesia The thoracoscope is removed and any collected fluid is drained from the chest cavity The first treatment with liposomal-cisplatin analogue L-NDDP is administered at this time into the intrapleural space over a 10 minute period Subsequent 10 minute intrapleural infusions of L-NDDP through a percutaneous catheter are administered every 3 weeks Treatment continues unless unacceptable toxic effects or disease progression occurs Antitumor activity is assessed 2 months after the second course of therapy and every 2 months thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| NCI-G99-1575 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9850 | None | None | None |
| MDA-FDR001234 | None | None | None |
| MDA-ID-95209 | None | None | None |