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

Stopped early · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT01695733

Run by

Washington University School of Medicine

People needed

21

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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