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

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00979381
First received: September 17, 2009
Last updated: March 17, 2010
Last verified: September 2009
  Purpose

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.


Condition Intervention
Renal Cell Carcinoma
GIST
Biological: influenza vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • cellular and humoral immune response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • times the influenza virus occurs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
3
healthy volunteers
Biological: influenza vaccine
influenza vaccination

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979381

Locations
Netherlands
University Medical Center Nijmegen st Radboud
Nijmegen, Netherlands, 6525 GH
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
  More Information

No publications provided

Responsible Party: C.M.L. van Herpen, UMCN St Radboud
ClinicalTrials.gov Identifier: NCT00979381     History of Changes
Other Study ID Numbers: UMCNONCO20084
Study First Received: September 17, 2009
Last Updated: March 17, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
sunitinib
sorafenib
immune response

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
Sorafenib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014