Clinical trial NCT00831857: VEGF Imaging in Renal Cell Carcinoma
Official title: 89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients locally advanced irresectable or metastatic renal cell cancer.

Brief summary: 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: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: after 2 and 6 weeks
Secondary outcomes:
measure: 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.
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Sjoukje F. Oosting, MD
role: PRINCIPAL_INVESTIGATOR
References: