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Vascular Endothelial Growth Factor (VEGF) Imaging Before and During Everolimus Treatment for Renal Cell Carcinoma (Everolimage)

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ClinicalTrials.gov Identifier: NCT01028638
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : January 28, 2015
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
S.F. Oosting, University Medical Center Groningen

Brief Summary:

Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients.

The investigators hypothesize that a decline in VEGF early during everolimus treatment in patients with metastatic renal cell carcinoma predicts treatment efficacy.

89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus treatment in 14 adult patients with metastatic renal cell carcinoma.


Condition or disease Intervention/treatment
Metastatic Renal Cell Carcinoma Other: 89Zr-bevacizumab PET scan

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Everolimus; a Pilot Study
Study Start Date : December 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Renal Cancer
Renal Cancer patients treated with everolimus
Other: 89Zr-bevacizumab PET scan

A tracer dose of 89Zr-bevacizumab (37 MBq, 5 mg protein dose) is given intravenously at day -3, day 11 and day 39.

PET scans are made on day 1, day 15 and day 43.

Other Name: VEGF imaging




Primary Outcome Measures :
  1. Change in 89Zr-bevacizumab uptake in tumor lesions between the baseline scan and the scan during treatment [ Time Frame: Baseline, 2 weeks and 6 weeks ]

Secondary Outcome Measures :
  1. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
whole blood, white blood cells, plasma, serum, urine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with metastatic renal cell carcinoma who will start treatment with everolimus.
Criteria

Inclusion Criteria:

  • metastatic renal cell cancer
  • Intention to start treatment with everolimus
  • WHO performance score ≤ 2
  • 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
  • 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

Exclusion Criteria:

  • formulated as "not" or "absence of" under inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028638


Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Novartis
Investigators
Principal Investigator: Sjoukje Oosting, MD University Medical Center Groningen

Responsible Party: S.F. Oosting, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01028638     History of Changes
Other Study ID Numbers: NL28799.042.09
METc2009.236
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by S.F. Oosting, University Medical Center Groningen:
VEGF imaging
everolimus
renal cell carcinoma
PET
bevacizumab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Everolimus
Sirolimus
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents