Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00722098
Status:
TERMINATED
Last Update Posted:
2013-07-08
First Post:
2008-07-23
Brief Title:
Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Melanoma Peptide-Loaded Dendritic Cell Vaccine in HLA-A0201 Patients With Stage IV Melanoma A Phase II Randomized Trial to Compare Vaccination With and Without Cyclophosphamide Treatment
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination due to lesser accrual and data analysis not done
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 determine whether the combination of chemotherapy Cyclophosphamide and CD34-DC vaccines results in the improved rate of clinical responses for stage IV melanoma patients
Detailed Description:
Vaccination of patients with metastatic melanoma using ex vivo generated dendritic cells DCs loaded with tumor-associated antigens have been shown to induce tumor-specific immunity against melanoma antigens measured by in vitro assays and in some cases tumor regression At the present time the numbers of recorded patients with metastatic melanoma who have been treated with DC vaccinations are too small to predict with certainty the future of overall therapeutic value of DC vaccinations in the management of patients with metastatic melanoma The purpose of this study is to gather data on feasibility and efficacy of novel combination therapy of CPA and a DC vaccine outlined in this protocol to treat metastatic melanoma
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