Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy



Status:Terminated
Conditions:Cancer, Influenza
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:September 2011
End Date:September 2013

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Influenza Vaccination Response in Patients With Non-Hematological Malignancies

This clinical trial studies the best time to administer the influenza vaccine to patients
with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different
times relative to chemotherapy may affect how well it works to help the body build an immune
response and prevent influenza in these patients.


Inclusion Criteria:

- Patients must have biopsy-confirmed non-hematological malignancy

- Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic
setting), excluding immunotherapy

- Patients must be of age >=18 years.

- Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to
influenza vaccination

- Ability of the patient (or legally authorized representative if applicable) to
understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have already received the influenza vaccine during the season in which
they are considered for eligibility will be excluded

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the influenza vaccine or egg allergies

- Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza
vaccination

- Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless
used as part of a chemotherapy regimen

- Patients must not be on any other agents that can suppress the immune system

- Planned concurrent therapy with radiation

- Uncontrolled illness at time of enrollment or influenza vaccination including, but not
limited to, ongoing or active febrile illness

- Psychiatric illness/social situations that would limit compliance with study
requirements

- Known immunosuppression eg. history of organ transplantation or known human
immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
are ineligible because they may not be able to mount an appropriate immune response

- History of influenza-like illness, defined as a temperature > 37.8 degree C with cough
or sore throat starting October 1, 2011 throughout the duration of the study

- Patient may not be scheduled to receive chemotherapy on a weekly basis.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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