Article
Clinical phase I/II trial to assess antitumor activity and tolerability of dacarbazine i.v. plus Imatinib (Glivec) orally in patients with metastatic malignant melanoma
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Published: | March 20, 2006 |
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At present, no treatment options are available for melanoma patients with advanced metastatic disease that provide either sufficient response rates or a significant prolongation of survival. Chemotherapy with dacarbacine (DTIC) does actually apply as the standard treatment regimen in advanced melanoma, leading to response rates between 9.9 and 18%. Imatinib inhibits selectively several tyrosine kinases, e.g. Abl, Kit, and platelet-derived growth factor receptors (PDGF-R), which have been shown to be expressed by melanoma cells. Used as a single agent in metastatic melanoma patients imatinib was not efficient. Therefore, a combination of DTIC (800 mg/m2 i.v., days 1 und 28) and Imatinib (400 mg/d p.os, days 2-27 and days 29-56) was studied in this clinical trial as a first-line treatment. In 15 evaluable patients no objective responses could be observed. Two patients (13.3%) had a stable disease and 13 patients (86.7%) had progressive disease. The median overall survival was 6 months (95% CI 2.88; 9.12 months), the median time to progression was 2 months. No grade 3 or 4 toxicity was observed using this combination treatment. In conclusion, DTIC and Imatinib is a well tolerated regimen. However, this study did not reveal an efficacy of imatinib combined with DTIC in metastatic melanoma.