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

The Washington University

Status and phase

Terminated

Phase 1

Conditions

Neoplasms

Treatments

Biological: trivalent influenza vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01695733

201010722

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.