A Study on the Safety and Immunogenicity of Combined Intradermal and Intravenous Administration of an Autologous mRNA Electroporated Dendritic Cell Vaccine in Patients With Previously Treated Unresectable Stage III or IV Melanoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bart Neyns, Universitair Ziekenhuis Brussel
First received: January 8, 2010
Last updated: August 21, 2012
Last verified: August 2012
This phase I study plan is divided in the following four phases:
- Eligibility Screen Phase (week -4 to -1): Following written informed consent patients with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an eligibility screen (incl. blood analysis and PET/CT-scan).
- TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC vaccine. Vaccine preparations will be manufactured and quality-controlled (during an interval of 4 weeks following the leucapheresis) and released for patient administration if the TriMix-DC preparation fulfills the predefined quality requirements.
- TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per antigen will be administered.
Patients will be allocated to three different cohorts:
- The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection.
- The second cohort 25% by iv and 75% by id injection.
- The third cohort 50% by iv and 50% by id injection.
- During the week following the administration of the fourth vaccine (= week 8), a DTH-test and punch biopsy of the injection site will be performed as well as a second leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT).
- A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (= 8w after the fourth vaccine).
- End of study visit: Patients will perform an "end of study visit" 8 weeks after the fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT).
- Follow-up Phase: survival data will be obtained until 3 years after the initiation of vaccine therapy or the time of death.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Universitair Ziekenhuis Brussel:
Primary Outcome Measures:
- a new tumor evaluation (PET/CT) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Document the anti-melanoma activity [ Time Frame: week 8, 16 and 24 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
eligible patients will undergo a leucapheresis for the preparation of autologous TriMix-DC vaccine.4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks.
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