Metastatic Melanoma Clinical Trial
Official title:
Bevacizumab, Dacarbazine and Interferon Alfa-2a Combination as a First-Line Therapy in Patients With Locally Advancing or Metastatic Melanoma
The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma.
Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and
after that numerous schedules and dacarbazine-based combinations have been studied in this
disease. DTIC as a single agent gives a response rate of only 20%, but there have been
efforts to improve this poor result by using DTIC in different combinations.Treatment of
melanoma with combination chemotherapy and interferon-α (IFN-α) has given 50-60% response
rates,but increase in the overall survival time has not been reached in controlled phase III
studies. Thus, standard reference therapy in treatment of metastatic melanoma still is
single dacarbazine or its combination with s.c. IFN-α. In addition, new studies with
melanoma cells in vitro show that dacarbazine causes transcriptional up-regulation of
vascular endothelial growth factor (VEGF), suggesting a potential clinical benefit of
combination of DTIC and anti-VEGF therapy. IFN-α has been used in adjuvant therapy and in
treatment of metastatic melanoma. IFN-α exerts its effects through antiproliferative,
apoptosis-inducing and particularly antiangiogenic effects in addition to immunologic
modulation.
The purpose of this study is to determine whether combination therapy with bevacizumab
(Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) can increase progression-free
survival and overall survival in patients with locally advancing or metastatic melanoma.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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