Status:

COMPLETED

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

Lead Sponsor:

Radboud University Medical Center

Conditions:

Renal Cell Carcinoma

GIST

Eligibility:

All Genders

18+ years

Brief Summary

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 patien...

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 m...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT00979381

Start Date

October 1 2008

End Date

November 1 2009

Last Update

March 18 2010

Active Locations (1)

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University Medical Center Nijmegen st Radboud

Nijmegen, Netherlands, 6525 GH