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

NCT00979381 | Completed

• 1 other identifier: UMCNONCO20084
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 patients with metastases of renal cell carcinoma or a GIST.

Conditions

Renal Cell Carcinoma; GIST

Keywords

sunitinib; sorafenib; immune response

Outcome Measures

Primary Outcomes (1)

• cellular and humoral immune response

  1 year

Secondary Outcomes (1)

• times the influenza virus occurs

  1 year

Study Arms (3)

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

2

patients with metastasized RCC who did not receive a systemic treatment for their RCC (nephrectomy is allowed)

Biological: influenza vaccine

3

healthy volunteers

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

influenza vaccination

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Center Nijmegen st Radboud

Nijmegen, 6525 GH, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• C.M.L. van Herpen, MD, Phd

  UMCN st Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: March 18, 2010

Record last verified: 2009-09

Locations

NL (1)