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

NCT ID: NCT01695733

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Schedule A

Influenza vaccination on the first day of chemotherapy

Group Type: EXPERIMENTAL

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Schedule B

Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy

Group Type: EXPERIMENTAL

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Interventions

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Flushield, Fluvirin, Fluzone, Influenza Vaccine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saiama Waqar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201010722

Identifier Type: -

Identifier Source: org_study_id