Metastatic Melanoma
Conditions
Keywords
melanoma, metastatic, bevacizumab
Brief summary
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.
Detailed description
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.
Interventions
DRUGBevacizumab (Avastin)
DRUGdacarbazine
DRUGinterferon-alfa-2a (Roferon-A)
Sponsors
University of Turku
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed malignant melanoma either locally progressing inoperable or metastatic * measurable/evaluable disease in accordance with RECIST criteria * WHO performance status 0-2 * normal organ function * signed written informed consent
Exclusion criteria
* unevaluable disease * major surgery within 28 days prior to day 0 * uncompleted radiotherapy * CNS metastases * serious non-healing wound or ulcer * bleeding diathesis or coagulopathy * uncontrolled hypertension * clinically significant cardiovascular disease * depression or psychosis, which needs medication * ongoing treatment with aspirin (\>325 mg/day) * pregnancy * any other serious or uncontrolled illness * previous chemotherapy for metastatic melanoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate according to RECIST criteria | — |
| Progression-free survival | — |
| Time to brain metastases | — |
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of this combination after every two cycles | — |
| Serum analysis of particular biochemical markers | — |
Countries
Finland
Outcome results
None listed