melanoma, imaging, VEGF, bevacizumab
Conditions
Interventions
1. Adminstration of 7.5 mg/kg bevacizumab
2. VEGF-SPECT imaging.
Sponsors
UMCG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Surgically resectable melanoma, stage III or IV; 2. WHO performance status 0-2; 3. Age >18 years; 4. Minimum required laboratory data: A. Hematology: Leucocytes 4,0-10,0x109/l; B. Biochemistry: bilirubin < 1.5 x upper normal limit; C. Serum creatinine within normal limits INR < 1.5. 5. Before patient registration/randomization, written informed consent must be given according to national and local regulations; 6. Able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy or biological therapy for metastatic disease; 2. Prior radiotherapy on the involved area; 3. Major surgery within 28 days before the initiation of the study; 4. Clinically significant cardiovascular disease; 5. 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; 6. CNS metastases (CT-Scan not mandatory); 7. Treatment with any investigational drug within 30 days before the start of the study; 8. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify biological effects of bevacizumab therapy and to visualize distribution kinetics and uptake of 111In-bevacizumab in the micro-environment of the tumor with gamma-camera imaging. | — |
Outcome results
None listed