Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125749
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2005-08-01
Brief Title:
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells Generated Ex Vivo From Monocytes and Loaded With Heat Treated Killed Allogeneic Melanoma Cells
Status:
COMPLETED
Status Verified Date:
2017-06
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 study is to test a novel dendritic cell DC vaccine in patients with Stage IV melanoma
Detailed Description:
A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research BIIR Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines Further studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8 cells Thus the strategy for this clinical trial will be to test recent laboratory findings in the clinical setting An additional objective of the study will be to determine the effectiveness of a frozen vaccine product which differs from previous vaccines that were manufactured fresh
This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma The trial will accrue a total of 30 subjects The primary goal of this trial will be to test the safetytolerabilityfeasibility of the vaccine preparation and the rate of objective clinical response A 15 objective response rate will be accepted in patients who have failed previous therapy with IL-2 andor dacarbazine DTIC andor temozolomide which are standard treatments for patients with malignant melanoma
Each subject will be given 7 initial injections in a fixed dose amount The first 4 doses will be given at 2-week intervals Weeks 0 2 4 and 6 the last 3 doses will be given at 4-week intervals Weeks 10 14 and 18 Those patients who exhibit stable disease partial response or complete response after 7 injections will be given 4 more vaccinations Each of these additional 4 vaccinations will be given 3 months apart Weeks 36 48 72 and 96 Scans and re-staging tests will be performed at scheduled intervals throughout the study
This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma The trial will accrue a total of 30 subjects The primary goal of this trial will be to test the safetytolerabilityfeasibility of the vaccine preparation and the rate of objective clinical response A 15 objective response rate will be accepted in patients who have failed previous therapy with IL-2 andor dacarbazine DTIC andor temozolomide which are standard treatments for patients with malignant melanoma
Each subject will be given 7 initial injections in a fixed dose amount The first 4 doses will be given at 2-week intervals Weeks 0 2 4 and 6 the last 3 doses will be given at 4-week intervals Weeks 10 14 and 18 Those patients who exhibit stable disease partial response or complete response after 7 injections will be given 4 more vaccinations Each of these additional 4 vaccinations will be given 3 months apart Weeks 36 48 72 and 96 Scans and re-staging tests will be performed at scheduled intervals throughout the 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