In this study we investigate the influence of the tyrosine kinase inhibitors sunitinib and sorafenib, on the normal humoral and cellular immune reponse to influenza vaccination in patients with metastases of renal cell carcinoma or a GIST.
ID
Source
Brief title
Condition
- Other condition
- Renal and urinary tract neoplasms benign
Synonym
Health condition
GIST
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
cellular and humoral immune response
Secondary outcome
times the influenzavirus occurs
Background summary
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 objective
In this study we investigate the influence of the tyrosine kinase inhibitors
sunitinib and sorafenib, on the normal humoral and cellular immune reponse to
influenza vaccination in patients with metastases of renal cell carcinoma or a
GIST.
Study design
This is an inventory study: we are looking for major differences between the
participating groups
Study burden and risks
- short questionaire
- 3x venapuncture (83 ml in 22 days)
- 1x throatspread in case of influenza
P.O. Box 9101
6500 HB Nijmegen
Nederland
P.O. Box 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
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
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25175.091.08 |