Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116363
Status:
UNKNOWN
Last Update Posted:
2008-04-01
First Post:
2005-06-28
Brief Title:
Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
Sponsor:
Introgen Therapeutics
Organization:
Introgen Therapeutics
Study Overview
Official Title:
Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 Ad-mda7 Administration in Patients With In Transit Melanoma
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patients immune system kill melanoma cells
Detailed Description:
INGN 241 is an adenoviral vector carrying the MDA-7 cDNA MDA-7 is a novel tumor suppressor molecule with cytokine properties recently designated as IL-24 Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration and has been well tolerated to date The primary objectives of the present study are to determine if INGN 241 injected into a melanoma in transit lesion can induce apoptosis in regional uninjected lesions and initiate systemic immune activation Secondary objectives include examination of specific immunity and of clinical response and toxicity
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 |
|---|---|---|---|
| 2003-0590 R43 CA 89778 | None | None | None |