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
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|ClinicalTrials.gov Identifier: NCT01066390|
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : May 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: TriMix-DC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||May 2014|
- Biological: TriMix-DC
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.
- a new tumor evaluation (PET/CT) [ Time Frame: 24 weeks ]
- Document the anti-melanoma activity [ Time Frame: week 8, 16 and 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066390
|Laken, Brussels, Belgium, 1090|
|Principal Investigator:||Bart Neyns, Professor||Universitair Ziekenhuis Brussel|