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


N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


- 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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

after 2 and 6 weeks

Safety Issue:

No

Principal Investigator

Sjoukje F. Oosting, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

Renimage Protocol

NCT ID:

NCT00831857

Start Date:

January 2009

Completion Date:

September 2011

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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