VEGF Imaging in Renal Cell Carcinoma - Full Text View

Sponsored by:	University Medical Centre Groningen
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00831857

Purpose

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.

Condition	Intervention
Renal Cell Carcinoma	Other: 89Zr-Bevacizumab PET-scan

MedlinePlus related topics: Nuclear Scans

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	89Zr-Bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

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. [ Time Frame: after 2 and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group A Treatment with sunitinib.	Other: 89Zr-Bevacizumab PET-scan At baseline, after two weeks of treatment and after 6 weeks of treatment.
Group B Treatment with bevacizumab and interferon	Other: 89Zr-Bevacizumab PET-scan At baseline, after two weeks of treatment and after 6 weeks 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients locally advanced irresectable or metastatic renal cell cancer.

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
left ventricular ejection fraction ≥ 50%
no clinically significant cardiovascular events or disease during the last 12 months
no ongoing full dose anticoagulant or anti platelet aggregation treatment
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
≥ 18 years
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831857

Contacts

Contact: Sjoukje F. Oosting, MD

+31 50 361 61 61

s.oosting@int.umcg.nl

Locations

Netherlands
University Medical Center Groningen	Recruiting
Groningen, Netherlands, 9700 RB
Contact: Sjoukje F. Oosting, MD +31 50 361 61 61 s.oosting@int.umcg.nl
Principal Investigator: Sjoukje F. Oosting, MD

Sponsors and Collaborators

University Medical Centre Groningen

Investigators

Principal Investigator:

Sjoukje F. Oosting, MD

University Medical Centre Groningen

More Information

No publications provided

Responsible Party:	University Medical Centre Groningen ( S.F. Oosting, MD )
Study ID Numbers:	Renimage Protocol
Study First Received:	January 28, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831857 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Interferons
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma

Renal Cancer
Urologic Diseases
Sunitinib
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009