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Datasets  >  clinical study dataset  >  DERMA-ER-DC 05 clinical tri...

DERMA-ER-DC 05 clinical trial of DC-based therapy of melanoma patients +/- ONTAK

clinical study dataset

We have data from a clinical trial with melanoma patients (stage IV, documented progress) receive DC transfected with RNA encoding MelanA, Mage3 and Survivin +/- E/L-selectin by the i.v. route. This DERMA-ER-DC 05 trial (multipeptide loaded cytokine matured moDC + prior Treg elimination by 3x ONTAK treatment [5µg/kg], 8 evaluated pat.) did not show any enhanced immune reponses compared to the equivalent cohort in the DERMA-ER-DC 04 trial.

Patient recruitment into the 2nd phase of the DERMA-ER-DC 06 trial has started (sequential adaptive design). Immunomonitoring of first patients showed efficient induction of broad immune responses.

However, we unexpectedly could not demonstrate any depletion of Tregs by ONTAK (ccoperation with P14). ONTAK treatment induced a transient depletion of all known DC subpopulations in the peripheral blood, a novel and very unexpected finding.

One possible reason for the discrepancies between our findings and published data could be the amount of ONTAK used in patients. We therefore filed an amendment allowing the inclusion of additional 4 patients, who will receive higher doses (12microg/kg 3x and 18microg/kg 1x) before vaccination. Taking into account direct effects of ONTAK on DC, patients will be vaccinated some days after last ONTAK treatment (as soon as blood DC have recovered to 50% of pre ONTAK amount).

created over 15 years ago (2 March 2009)    last modified over 12 years ago (10 October 2011)   [ RDF Rdf ]   [ RelFinder Relfinder ]