Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272649
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2006-01-06
Brief Title:
Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
Sponsor:
Argos Therapeutics
Organization:
Argos Therapeutics
Study Overview
Official Title:
A Phase III Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-03
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:
The purpose of this trial is to examine the safety feasibility immunological response and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer
Detailed Description:
In this study a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study clinical protocol MB-002-003 While both processes are based on individual subject autologous tumor RNA and autologous monocyte derived DCs the maturation of DCs in this newly modified process involves an altered regimen of culture with cytokines In addition huCD40L mRNA is added to the autologous expanded tumor total mRNA for electroporation These changes promise a much improved migration and activity profile of the DC-Immunotherapeutic product in RCC subjects
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 |
|---|---|---|---|
| Figlin-05-03-099-01 | None | None | None |
| Bukowski-8077 | None | None | None |
| Logan-0506-05 | None | None | None |
| Drabkin-05-0167 | None | None | None |
| White-04-05-01A | None | None | None |