Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050323
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2002-12-04
Brief Title:
SafetyEfficacy of a Vaccine Prepared From Dendritic Cells Combined With Tumor Cells to Treat Advanced Kidney Cancer
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase 12 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine the safety of injections prepared from donor blood cells fused to a patients own tumor cells which are then used to treat advanced Stage IV kidney cancer renal cell carcinoma or RCC The study will also explore the effect the injections have on the size of the tumor and the response in the patients immune system following administration
Detailed Description:
Approximately 30000 new cases of kidney cancer will be diagnosed in the US in 2002 with renal cell carcinoma RCC being the most commonly diagnosed type For patients with locally advanced or metastatic disease the treatment options are extremely limited and additional options are warranted Although RCC is generally considered resistant to chemotherapy spontaneous regressions in patients with metastatic disease have led to research involving immune-mediated therapeutic approaches Clinical responses have been observed and additional immune-modulating therapeutics are being studied
Several such approaches have used dendritic cells DCs which are known to be potent antigen presenting cells An antigen is a protein that when shown to the immune system in the right way can trigger the cells of the immune system to recognize remember and eliminate other cells that also display that specific antigen The cancerous cells in tumors present antigens in such a way that the bodys immune system often fails to recognize and eliminate them It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner thus allowing the bodys immune system to recognize the tumor antigens on the cancer itself If this occurs the patients immune system may be specifically stimulated producing a clinically meaningful immune response against the tumor
In this study DCs produced from healthy volunteer donors allogeneic DCs will be fused to the patients own tumor cells autologous tumor cells using an electrical current The fused dendritictumor cells will be returned to the patient in a series of vaccines six weeks apart
The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will with limited associated toxicity present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response
Several such approaches have used dendritic cells DCs which are known to be potent antigen presenting cells An antigen is a protein that when shown to the immune system in the right way can trigger the cells of the immune system to recognize remember and eliminate other cells that also display that specific antigen The cancerous cells in tumors present antigens in such a way that the bodys immune system often fails to recognize and eliminate them It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner thus allowing the bodys immune system to recognize the tumor antigens on the cancer itself If this occurs the patients immune system may be specifically stimulated producing a clinically meaningful immune response against the tumor
In this study DCs produced from healthy volunteer donors allogeneic DCs will be fused to the patients own tumor cells autologous tumor cells using an electrical current The fused dendritictumor cells will be returned to the patient in a series of vaccines six weeks apart
The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will with limited associated toxicity present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response
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