The effect of sorafenib (Bay-43-9006) on 111Indium labeled chimeric monoclonal antibody G250 or 111Indium labeled bevacizumab uptake in patients with clear cell RCC (ccRCC).
- Conditions
- angiogenesiskidney cancer10038364
- Registration Number
- NL-OMON30815
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
-Renal cell carcinoma patients planned for surgery (nephrectomy/metastectomy)
-Karnofsky > 60 %
-age over 18 years
-signed informed consent
Exclusion Criteria
-Known subtype other than clear cell RCC
-Pre-exposure to murine/chimeric antibody therapy
-Chemotherapy, immunotherapy or radiation therapy within 4 weeks prior to start of study. Palliative limited field external radiation for fracture prevention is allowed
-Diabetes Mellitus
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective<br /><br>To determine the effect of sorafenib treatment on In-111-cG250 uptake of the<br /><br>tumor<br /><br>To determine the effect of sorafenib treatment on In-111-bevacizumab uptake of<br /><br>the tumor</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective<br /><br>Immunohistochemical analysis of CA-IX expression, (p)VHL status, HIF1-a, VEGF<br /><br>and PDGF expression, apoptosis and necrosis of surgical specimen, to<br /><br>investigate whether the clinical effect of sorafenib is based on angiogenesis,<br /><br>or if other mechanisms play a role.</p><br>