A Phase 2 interventional study of Bevacizumab (Avastin) and dacarbazine in Metastatic Melanoma, sponsored by University of Turku. Completed at 3 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-03.
Sponsored by University of Turku · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 27 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Response rate according to RECIST criteria
Progression-free survival
Time to brain metastases
Overall survival
To evaluate safety of this combination after every two cycles
Serum analysis of particular biochemical markers
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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University of Turku