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)
18 Years
N/A
Both
Renal Cell Carcinoma, GIST
Trial Information
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)
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
cellular and humoral immune response
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
C.M.L. van Herpen, MD, Phd
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMCN st Radboud
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
UMCNONCO20084
NCT ID:
NCT00979381
Start Date:
October 2008
Completion Date:
November 2009
Related Keywords:
- Renal Cell Carcinoma
- GIST
- sunitinib
- sorafenib
- immune response
- Carcinoma
- Carcinoma, Renal Cell
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