VEGF Imaging in Renal Cell Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Other: 89Zr-Bevacizumab PET-scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Treatment with sunitinib. | Other: 89Zr-Bevacizumab PET-scan<br>* At baseline, after two weeks of treatment and after 6 weeks of treatment.<br>|
| Group B<br>Treatment with bevacizumab and interferon | Other: 89Zr-Bevacizumab PET-scan<br>* At baseline, after two weeks of treatment and after 6 weeks of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change in SUV between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC. |  | after 2 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions. |  | 3 months after treatment |