CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 target
Drug / intervention
Peptide-pulsed dendritic cellsbiological
Likely dose
Not stated in record
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Search/NCT00243594
NCT00243594Phase 2Completed

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

Radboud University Medical Center·interventional·Posted Oct 24, 2005·Updated Feb 19, 2009

In Brief

A Phase 2 clinical trial evaluating Peptide-pulsed dendritic cells for Melanoma Stage III or IV. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2005
Enrollment StartSep 1, 1999
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.7 years ago

Interventions

Peptide-pulsed dendritic cellsbiological

peptide-pulsed dendritic cells