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

Study Overview
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Brief Summary
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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.

Official Title
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Influenza Vaccination Response in Patients With Non-Hematological Malignancies

Conditions
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Neoplasms

Intervention / Treatment
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* Biological: trivalent influenza vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schedule A<br>Influenza vaccination on the first day of chemotherapy | Biological: trivalent influenza vaccine<br> <br> * Other names: Flushield, Fluvirin, Fluzone, Influenza Vaccine;|
| Experimental: Schedule B<br>Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy | Biological: trivalent influenza vaccine<br> <br> * Other names: Flushield, Fluvirin, Fluzone, Influenza Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule. | We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine. | 4 weeks from the influenza vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the presence of post-vaccination adverse events |  | 4 weeks from the influenza vaccine |