Status:
COMPLETED
Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma
Lead Sponsor:
University of Turku
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 meta...
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 si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00308607
Start Date
August 1 2005
End Date
April 1 2009
Last Update
April 3 2009
Active Locations (3)
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1
Kuopio University Hospital
Kuopio, Kuopio, Finland, FIN-70211
2
Oulu University Hospital
Oulu, Oulu, Finland, FIN-90029
3
Tampere University Hospital
Tampere, Pirkanmaa, Finland, FIN-33521