melanoma cancer skin cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Surgically resectable melanoma. • WHO performance status 0-2. • Age >18 years. • Minimum required laboratory data: • Hematology: Leucocytes 4,0-10,0x109/l. • Biochemistry: bilirubin
Exclusion criteria
Exclusion criteria: • Prior chemotherapy or biological therapy for metastatic disease. • Prior radiotherapy on the involved area. • Major surgery within 28 days before the initiation of the study. • Clinically significant cardiovascular disease. • Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause. • CNS metastases (CT-Scan not mandatory). • Treatment with any investigational drug within 30 days before the start of the study. • Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments will consist of evaluating labatory parameters and adverse events according to NCI CTCAE 3.0. The following variables will be analyzed to assess the effectiveness of bevacizumab in the treatment of melanoma tumors: • Biological parameters. • Histopathological parameters. • 111In-bevacizumab distribution kinetics by gamma-camera imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed