Monocentric Pilot Study Investigating the Metabolic Activity of Melanoma in Vivo During Sorafenib and Dacarbazine
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
Investigation of the metabolic activity of sorafenib and sorafenib plus dacarbazine on
melanoma metastasis in patients with melanoma stage III or IV on the basis of PET/CT, LDH and
S-100 evaluation. As we hypothezise a direct influence on the transcriptome by these drugs
via antiproliferative or apoptotic signals, biopsies of melanoma skin metastases will be
assessed with microarrays and direct changes will be revealed. If positive effects on the
transcriptional profiles of metastases are revealed, patients with metastatic melanomas would
benefit from these drugs resulting in tumor regressions.
Therefore, a total of 12 patients with skin- or superficial lymph node metastases with a
diameter of at least 1 cm will be chosen for sorafenib therapy over 56 days per os twice
daily with each 400 mg and, additionally, on day 14 and 42, intravenous dacarbazine infusion
(volume depending on the body surface area (1000 mg/m2)). Before treatment with sorafenib,
before treatment with dacarbazine, and after treatment, S100 and LDH will be measured in
serum, PET/CT will be conducted and biopsy will be taken out of one skin metastasis on the
same day.