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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).

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). - effect of sorafenib on imaging of ccRCC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30815
Enrollment
20
Registered
2007-03-09
Start date
2006-11-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

angiogenesis kidney cancer

Interventions

20 patients: All patients will undergo two PET-scans and will take from week 2-5 every day 400mg sorafenib orally. 10 patients will recieve 200 MBq/10 mg 111In-cG250 in 50 ml isotonic saline/5 % Hum

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Renal cell carcinoma patients planned for surgery (nephrectomy/metastectomy) -Karnofsky > 60 % -age over 18 years -signed informed consent

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
Secondary objective Immunohistochemical analysis of CA-IX expression, (p)VHL status, HIF1-a, VEGF and PDGF expression, apoptosis and necrosis of surgical specimen, to investigate whether the clinical effect of sorafenib is based on angiogenesis, or if other mechanisms play a role.

Primary

MeasureTime frame
Primary objective To determine the effect of sorafenib treatment on In-111-cG250 uptake of the tumor To determine the effect of sorafenib treatment on In-111-bevacizumab uptake of the tumor

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)