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ONDERZOEK NAAR EFFECT VAN BEVACIZUMAB BEHANDELING BIJ MELANOMEN M.B.V. MOLECULAIRE BEELDVORMING.


- candidate number6297
- NTR NumberNTR1941
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-aug-2009
- Secondary IDs 
- Public TitleONDERZOEK NAAR EFFECT VAN BEVACIZUMAB BEHANDELING BIJ MELANOMEN M.B.V. MOLECULAIRE BEELDVORMING.
- Scientific TitleIdentification of biological effects of bevacizumab in surgically resectable malignant melamoma.
- ACRONYMN/A
- hypothesisTo identify biological effects of bevacizumab and to visualize distribution kinetics of 111In-bevacizumab with gamma-camera imaging.
- Healt Condition(s) or Problem(s) studiedBevacizumab , Melanoma, Imaging, VEGF
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 11-jan-2007
- planned closingdate
- Target number of participants10
- Interventions1. Adminstration of 7.5 mg/kg bevacizumab;
2. VEGF-SPECT imaging.
- Primary outcomeTo 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 outcomeN/A
- TimepointsVEGF-SPECT imaging at baseline and 2 weeks following bevacizumab treatment prior to surgical resection.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryObservational 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.
- Main changes (audit trail)
- RECORD9-aug-2009 - 11-okt-2009


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