No registrations found.
ID
Source
Brief title
Health condition
melanoma, imaging, VEGF, bevacizumab
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
Observational study evaluating the anti-angiogenic and apoptotic response of bevacizumab in patients with surgically resectable melanoma.
Patients with surgically resectable melanoma, who are planned for surgery will be treated neo-adjuvant with bevacizumab therapy. The anti-angiogenic and apoptotic response will be evaluated by measuring hematological and histological parameters. The distribution kinetics of 111In-bevacizumab will be visualized by gamma-camera imaging. The patients will receive two injections of 111In-bevacizumab and four gamma-camera scans. The first 2 scans will serve as a baseline. After the second scans it will be possible to compare imaging data before and after treatment and hereby evaluate tumor response.
Study objective
To identify biological effects of bevacizumab and to visualize distribution kinetics of 111In-bevacizumab with gamma-camera imaging.
Study design
VEGF-SPECT imaging at baseline and 2 weeks following bevacizumab treatment prior to surgical resection.
Intervention
1. Adminstration of 7.5 mg/kg bevacizumab;
2. VEGF-SPECT imaging.
[default]
The Netherlands
[default]
The Netherlands
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1831 |
| NTR-old | NTR1941 |
| Other | : |