NCT05799612

Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Angiosarcoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given by IV (vein)
BIOLOGICAL	mRNA plus Lysate-loaded Dendritic Cell Vaccine	Given by IV (vein)
DRUG	PEGYLATED-INTERFERON ALPHA-2A	Given by IV (vein)
DRUG	Filgrastim	Given by IV (vein)

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-11-05
• Completion: 2024-11-05
• First posted: 2023-04-05
• Last updated: 2026-02-13

Regulatory

• FDA-regulated drug study