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

NCT01028638 | Completed

• 2 other identifiers: NL28799.042.09METc2009.236
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

VEGF imaging; everolimus; renal cell carcinoma; PET; bevacizumab

Outcome Measures

Primary Outcomes (1)

• Change in 89Zr-bevacizumab uptake in tumor lesions between the baseline scan and the scan during treatment

  Baseline, 2 weeks and 6 weeks

Secondary Outcomes (1)

• Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment

  3 months

Study Arms (1)

Renal Cancer

Renal Cancer patients treated with everolimus

Other: 89Zr-bevacizumab PET scan

Interventions

89Zr-bevacizumab PET scan OTHER

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.

Also known as: VEGF imaging

Renal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic renal cell carcinoma who will start treatment with everolimus.

You may qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Novartis: collaborator

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• van Es SC, Brouwers AH, Mahesh SVK, Leliveld-Kors AM, de Jong IJ, Lub-de Hooge MN, de Vries EGE, Gietema JA, Oosting SF. 89Zr-Bevacizumab PET: Potential Early Indicator of Everolimus Efficacy in Patients with Metastatic Renal Cell Carcinoma. J Nucl Med. 2017 Jun;58(6):905-910. doi: 10.2967/jnumed.116.183475. Epub 2017 Jan 12.

  PMID: 28082434 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, white blood cells, plasma, serum, urine

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sjoukje Oosting, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)