Study of the Immunoresponse in Patients Treated With a Tyrosine Kinase Inhibitor

March 17, 2010 updated by: Radboud University Medical Center

Study to the Humoral and Cellular Immunoresponse After Influenza Vaccination in Patients With Metastasized RCC or GIST Treated With a Tyrosine Kinase Inhibitor(Sunitinib or Sorafenib)

In this study the researchers investigate the influence of the tyrosine kinase inhibitors sunitinib and sorafenib, on the normal humoral and cellular immuno response to influenza vaccination in patients with metastases of renal cell carcinoma or a GIST.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When cure is not longer possible, cancer patients enter the palliative phase. For many types of cancer several treatment options are available. The goal of this treatment is to prolong survival, but maintenance or even improvement of quality of life is of equal importance. The currently available systemic treatment options consist of conventional cytotoxic therapy, hormonal therapy, immunotherapy and the so-called targeted therapies. Combinations of these therapies are also being used. Targeted therapy concerns the application of a new class of drugs that are specifically directed against one or more well-defined molecular targets that are relevant for carcinogenesis, cell cycle regulation, tumour progression, metastasis, tumour angiogenesis and/or apoptosis. Today, the most successful drugs in this class are directed against the vascular endothelial growth factor (VEGF) and the epidermal growth factor receptor (EGFR). There is an explosive development ongoing in this field and many new drugs become available that have new targets or inhibit a combinations of targets. Meanwhile, targeted therapy has shown efficacy in many types of cancer and is registered for several indications. The toxicity profile of targeted therapies is still largely unknown, and the aetiology of many known side effects has not been clarified. At the moment, three targeted therapies that are directed against VEGF are registered and used in the Netherlands: Sunitinib (Sutent®) and Sorafenib (Nexavar ®) both oral drugs and Bevacizumab (Avastin®), an intravenously drug. Clinical experience and some mouse studies show that targeted therapies could have a negative effect on the immune response. This can be of great influence on patients who are treated with this type of drug.

Especially because these drug will be used chronically and sometimes for years and infections can have a large influence on the health and quality of life of these patients.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6525 GH
        • University Medical Center Nijmegen st Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastasized renal cell carcinoma or GIST who have been treated with sunitinib or sorafenib for at least 4 weeks, or patients with metastasized RCC who did not receive a systemic treatment for their RCC (nephrectomy is allowed)

  • Patients who are indicated for influenza vaccination and and have been summoned for this vaccination by their GP
  • healthy volunteers who have been summoned by theire GP to receive a influenza vaccin

Description

Inclusion Criteria:

  • Patients with metastasized renal cell carcinoma or GIST who have been treated with sunitinib or sorafenib for at least 4 weeks, or patients with metastasized RCC who did not receive a systemic treatment for their RCC (nephrectomy is allowed)
  • Patients who are indicated for influenza vaccination and and have been summoned for this vaccination by their GP
  • age ≥18 years (for the healthy volunteers: age≥ 60 years)
  • signed Informed Consent Form

Exclusion Criteria:

  • patients with an identified immunodeficiency disorder
  • patients that have been treated with corticosteroids in the past 2 weeks or who are still using these (except for a short period <10 days)
  • patients that are treated with immunotherapy in the last year (ex. interferon-alpha of IL-2) or who have received another form of targeted therapy (ex. bevacizumab).
  • patients with symptoms of influenza at the time of vaccination
  • patient with an allergy for chicken-eggwhite

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3
healthy volunteers
Biological: influenza vaccine
influenza vaccination
1
Patients with metastasized renal cell carcinoma or GIST who have been treated with sunitinib or sorafenib for at least 4 weeks
Biological: influenza vaccine
influenza vaccination
2
patients with metastasized RCC who did not receive a systemic treatment for their RCC (nephrectomy is allowed)
Biological: influenza vaccine
influenza vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cellular and humoral immune response
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
times the influenza virus occurs
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCNONCO20084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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