Clinical trial · Observational
Study of the Immunoresponse in Patients Treated With a Tyrosine Kinase Inhibitor
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)
NCT00979381CI-TRIAL-00003276completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| influenza vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- Patients with metastasized renal cell carcinoma or GIST who have been treated with sunitinib or sorafenib for at least 4 weeks
- interventionNames
- Biological: influenza vaccine
- label
- 2
- description
- patients with metastasized RCC who did not receive a systemic treatment for their RCC (nephrectomy is allowed)
- interventionNames
- Biological: influenza vaccine
- label
- 3
- description
- healthy volunteers
- interventionNames
- Biological: influenza vaccine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.