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

This study has been terminated.
(no longer had funding to continue)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01695733
First received: September 26, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Neoplasms
Biological: trivalent influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Influenza Vaccination Response in Patients With Non-Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule. [ Time Frame: 4 weeks from the influenza vaccine ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Report the presence of post-vaccination adverse events [ Time Frame: 4 weeks from the influenza vaccine ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Schedule A
Influenza vaccination on the first day of chemotherapy
Biological: trivalent influenza vaccine
Other Name: Flushield, Fluvirin, Fluzone, Influenza Vaccine
Experimental: Schedule B
Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy
Biological: trivalent influenza vaccine
Other Name: Flushield, Fluvirin, Fluzone, Influenza Vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695733

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Saiama Waqar, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01695733     History of Changes
Other Study ID Numbers: 201010722
Study First Received: September 26, 2012
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014