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Clear Cell Renal Cell CarcinomaNCT00602862

Effect of Sorafenib on ccRCC Uptake of Radiolabeled Bevacizumab or cG250

A study testing Sorafenib, 111Indium-bevacizumab and 111Indium-cG250 in people with Clear Cell Renal Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sorafenib is a tyrosine kinase inhibitor that is registered for the treatment of metastasized clear cell Renal Cell Carcinoma (ccRCC). It inhibits signal transduction of the Vascular Endothelial Growth Factor Receptor (VEGFR) and the Platelet Derived Growth Factor Receptor (PDGFR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
Sorafenib, 111Indium-bevacizumab and 111Indium-cG250
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteNetherlands
Study dates
Jul 2007to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Renal cell carcinoma patients planned for surgery (nephrectomy/metastasectomy)
  • Karnofsky > 70 %
  • Laboratory values within 14 days prior to start:
  • White blood cells (WBC) > 3.5 x 109/L
  • Platelets > 100 x 109/L
  • Hemoglobin > 6 mmol/L
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  • Total bilirubin < 1.5 upper limit of normal (ULN)
  • ASAT, ALAT < 2.5 x ULN (<5 x in case of liver metastases)
  • Lactate dehydrogenase (LDH) > 1.5. ULN
  • Serum creatinine < 2 x ULN
  • Amylase and Lipase < 1.5 ULN
  • Negative pregnancy test in premenopausal women
  • Age over 18 years
  • Signed informed consent
  • Life expectancy > 24 weeks
  • PT/APTT/ INR < 1.5 ULN
  • No current use of coumarin derivatives

Who cannot join

  • Known subtype other than clear cell RCC
  • Pre-exposure to murine/chimeric antibody therapy
  • Known brain metastases
  • Untreated hypercalcemia
  • Uncontrolled hypertension
  • Concurrent therapeutic anticoagulation
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  • Chemotherapy, immunotherapy or radiation therapy within 4 weeks prior to start of study. Palliative limited field external radiation for fracture prevention is allowed
  • Cardiac arrhythmias requiring antiarrhythmics (beta-blockers, digoxin), symptomatic coronary artery disease and congestive heart failure New York Heart Association III or IV.
  • Previous malignancy < 2 years prior to the study (except for cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumours (Ta, Tis, T1)
  • Any medical condition present that in the opinion of the investigator will affect patients' clinical status. No other concurrent malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix.
  • Active clinically serious bacterial or fungal infections (< grade 2 NCI-CTC version 3)
  • Known history of Human Immunodeficiency virus (HIV) infection or chronic hepatitis B/C.
  • Prior use of Raf-kinase inhibitors, MEK and Farnesyl transferase inhibitors
  • Prior use of Bevacizumab and all other drugs that target VEGF/ VEGF-receptors
  • Use of antiepileptic drugs
  • Pregnancy and lactation

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Center

    Nijmegen, Gelderland, 6500 HB

Other trials in Netherlands

About this study

Official title: The Effect of Sorafenib (Nexavar®) on 111-Indium Labeled Chimeric Monoclonal Antibody G250 or 111-Indium Labeled Bevacizumab (Avastin®) Uptake in Patients With Clear Cell RCC (ccRCC)

Sorafenib is a tyrosine kinase inhibitor that is registered for the treatment of metastasized clear cell Renal Cell Carcinoma (ccRCC). It inhibits signal transduction of the Vascular Endothelial Growth Factor Receptor (VEGFR) and the Platelet Derived Growth Factor Receptor (PDGFR). In the tumorigenesis of ccRCC, VEGF and PDGF are upregulated due to the defective Von-Hippel-Lindau (VHL) gene. CcRCC has a high Interstitial Fluid Pressure (IFP) and Tumor Microvascular Density (TMD), hampering the delivery of chemotherapeutics and monoclonal antibodies (mAbs). It was hypothesized that antiangiogenic compounds decrease tumor IFP and TMD, thus normalizing tumor vasculature, before diminishing tumor vasculature. Bevacizumab is an anti-VEGF mAb which depletes soluble VEGF from plasma, depriving VEGFR of its ligand. Chimeric monoclonal antibody cG250 recognizes carbonic anhydrase IX (CAIX), an antigen that is abundantly expressed in Renal Cell Carcinoma (RCC) and has limited expression in normal tissue. The aim of this study was to investigate the effect of Sorafenib on ccRCC physiology, by determining tumor uptake of 111In labeled cG250 or 111In labeled Bevacizumab.

Being tested
Sorafenib, 111Indium-bevacizumab, 111Indium-cG250
Keywords
Angiogenesis inhibitors
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called Bevacizumab, Avastin, Nexavar, cG250

    Sorafenib 200 mg 2dd2 po for 4 weeks before surgery

  • 111Indium-bevacizumabDrug

    Also called avastin, indium

    100 MBq / 1 mg 111Indium/bevacizumab iv

  • 111Indium-cG250Drug

    Also called rencarex, indium

    100 MBq / 10 mg 111Indium-cG250 iv

Study groups in NCT00602862
Study groupRoleWhat they receive
1Experimental10 Patients planned to undergo (partial) nephrectomy or metastasectomy receive an iv injection of 100 MBq/1mg 111In-Bevacizumab. Patients are then treated with Sorafenib 200 mg 2dd2 po for 4 weeks. In the last week of treatment, the same injection is given to determine tumor accumulation of the radiolabeled mAb after Sorafenib treatment. Whole-body scintigraphic images are recorded 1 week after both injections to calculate tumor uptake. After Sorafenib treatment, patients will undergo surgery.
Receives: Drug: Sorafenib; Drug: 111Indium-bevacizumab
2Experimental10 Patients planned to undergo (partial) nephrectomy or metastasectomy receive an iv injection of 100 MBq/10mg 111In-cG250. Patients are then treated with Sorafenib 200 mg 2dd2 po for 4 weeks. In the last week of treatment, the same injection is given to determine tumor accumulation of the radiolabeled mAb after Sorafenib treatment. Whole-body scintigraphic images are recorded 1 week after both injections to calculate tumor uptake. After Sorafenib treatment, patients will undergo surgery.
Receives: Drug: Sorafenib; Drug: 111Indium-cG250
3Active comparator5 Patients planned to undergo (partial) nephrectomy or metastasectomy receive an iv injection of 100 MBq/1mg 111In-Bevacizumab. Whole-body scintigraphic images are recorded 1 week after the injection to calculate tumor uptake. Hereafter, patients will undergo surgery.
Receives: Drug: 111Indium-bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the effect of sorafenib treatment on 111In-cG250 uptake of the tumor

    Measured: pre-surgery

  2. To determine the effect of sorafenib treatment on 111In-bevacizumab uptake of the tumor

    Measured: pre-surgery

Secondary outcomes (1)

  1. Immunohistochemical analysis of CA-IX expression, (p)VHL status, HIF1-a, VEGF and PDGF expression, apoptosis and necrosis of surgical specimen

    Measured: within 6 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00602862
Sponsor's protocol ID
Sorafenib-mAbs
Status last verified
Feb 2012
First submitted
3 Jan 2008
Last updated
2 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Desar IM, Stillebroer AB, Oosterwijk E, Leenders WP, van Herpen CM, van der Graaf WT, Boerman OC, Mulders PF, Oyen WJ. 111In-bevacizumab imaging of renal cell cancer and evaluation of neoadjuvant treatment with the vascular endothelial growth factor receptor inhibitor sorafenib. J Nucl Med. 2010 Nov;51(11):1707-15. doi: 10.2967/jnumed.110.078030. Epub 2010 Oct 18.

    PubMed 20956472

Questions about this trial

What is this clinical trial studying?

A study testing Sorafenib, 111Indium-bevacizumab and 111Indium-cG250 in people with Clear Cell Renal Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the effect of sorafenib treatment on 111In-cG250 uptake of the tumor (time frame: pre-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00602862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.

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