Vascular Endothelial Growth Factor (VEGF) Imaging Before and During Everolimus Treatment for Renal Cell Carcinoma (Everolimage)
This study is currently recruiting participants.
Verified January 2013 by University Medical Centre Groningen
Sponsor:
University Medical Centre Groningen
Collaborator:
Novartis
Information provided by (Responsible Party):
S.F. Oosting, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01028638
First received: December 8, 2009
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Metastatic Renal Cell Carcinoma |
Other: 89Zr-bevacizumab PET scan |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Everolimus; a Pilot Study |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Groningen:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, white blood cells, plasma, serum, urine
| Estimated Enrollment: | 14 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028638
Contacts
| Contact: Sjoukje Oosting, MD | + 31 50 3612821 | s.oosting@int.umcg.nl |
| Contact: Jourik Gietema, MD PhD | +31 50 3612821 | j.a.gietema@int.umcg.nl |
Locations
| Netherlands | |
| University Medical Centre Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Principal Investigator: Sjoukje Oosting, MD | |
Sponsors and Collaborators
University Medical Centre Groningen
Novartis
Investigators
| Principal Investigator: | Sjoukje Oosting, MD | University Medical Centre Groningen |
More Information
No publications provided
| Responsible Party: | S.F. Oosting, Principal investigator, University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT01028638 History of Changes |
| Other Study ID Numbers: | NL28799.042.09, METc2009.236 |
| Study First Received: | December 8, 2009 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by University Medical Centre 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 Everolimus Sirolimus Bevacizumab |
Endothelial Growth Factors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Growth Substances Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013