Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
Phase 1
Withdrawn
- Conditions
- Angiosarcoma
- Interventions
- Biological: mRNA plus Lysate-loaded Dendritic Cell VaccineDrug: PEGYLATED-INTERFERON ALPHA-2A
- Registration Number
- NCT05799612
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation/Deescalation PEGYLATED-INTERFERON ALPHA-2A Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen Dose Escalation/Deescalation mRNA plus Lysate-loaded Dendritic Cell Vaccine Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen Dose Escalation/Deescalation Paclitaxel Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen Dose Escalation/Deescalation Filgrastim Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 through study completion; an average of 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States