Clinical trial NCT01695733: Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy
Official title: Influenza Vaccination Response in Patients With Non-Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-09-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
timeFrame: 4 weeks from the influenza vaccine
Secondary outcomes:
measure: Report the presence of post-vaccination adverse events
timeFrame: 4 weeks from the influenza vaccine
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Saiama Waqar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: