VEGF Imaging in Renal Cell Carcinoma

89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study

The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.

• To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon.
• To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response.
• To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.

Inclusion criteria:

• locally advanced irresectable or metastatic renal cell cancer
• no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)
• no uncontrolled hypertension
• no clinically significant cardiovascular events or disease during the last 12 months
• no surgery in the last 4 weeks
• no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
• no treatment with a tyrosine kinase inhibitor during the last 4 weeks
• measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray > 20 mm, Spiral CT scan > 10 mm, non-spiral CT scan > 20 mm
• clear cell histology component
• not pregnant or nursing
• women of childbearing potential must use effective contraception
• absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• before patient randomization, written informed consent must be given according to GCP, and local regulations