Melanoma Stage III or IV Clinical Trial
Official title:
Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration
Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As
such they are currently used in clinical vaccination protocols in cancer patients, and both
immunological and clinical responses have been observed. For these therapies accurate
delivery to target organs is essential. Correct delivery and subsequent migration of
vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation
of the immune system. Currently it is not known what the best route of administration is for
DC vaccines.
Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor
DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph
node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the
clinically approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine
and injected either in the skin or directly in lymph nodes under ultrasound guidance. Two
days after vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes
are then resected. Subsequently patients receive 3 more vaccination with DCs. During and
after therapy immune responses against the used melanoma peptides are monitored.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00794235 -
Monocentric Pilot Study Investigating the Metabolic Activity of Melanoma in Vivo During Sorafenib and Dacarbazine
|
Phase 2 | |
| Completed |
NCT00243529 -
Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
|
Phase 1/Phase 2 |