Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT05799612
Status:
WITHDRAWN
Last Update Posted:
2024-11-08
First Post:
2023-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
Status:
WITHDRAWN
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma
Detailed Description:
Objectives:
Primary objective:
•To determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with tumor lysate plus mRNA to patients with cutaneous head \& neck angiosarcoma as adjuvant therapy.
Secondary objective:
• To assess the recurrence free survival and overall survival in treated patients in order to make initial assessment of activity of this therapeutic approach
Exploratory Objectives:
• To quantitate immune responses in patients who receive autologous DCs loaded with tumor lysate plus mRNA
Primary objective:
•To determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with tumor lysate plus mRNA to patients with cutaneous head \& neck angiosarcoma as adjuvant therapy.
Secondary objective:
• To assess the recurrence free survival and overall survival in treated patients in order to make initial assessment of activity of this therapeutic approach
Exploratory Objectives:
• To quantitate immune responses in patients who receive autologous DCs loaded with tumor lysate plus mRNA
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-02650 | OTHER | NCI-CTRP Clinical Trials Registry | View |