Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01474174
First received: October 21, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors


Condition Intervention Phase
Central Nervous System Neoplasm
Biological: trivalent influenza vaccine
Other: laboratory biomarker analysis
Phase 0

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up. Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40. The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured. Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.


Secondary Outcome Measures:
  • Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Relationship between a variety of clinical factors and seroconversion following influenza vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Relationship between serologic markers of immune function and response to vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2011
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
Biological: trivalent influenza vaccine
Given IM
Other Names:
  • FluMist
  • Flushield
  • Fluvirin
  • Fluzone
  • Influenza Vaccine
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.

SECONDARY OBJECTIVES:

I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.

II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.

III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.

TERTIARY OBJECTIVES:

I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.

After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with primary central nervous system turmors

Criteria

Inclusion Criteria:

  • Patients must have a clinical diagnosis of a primary central nervous system tumor
  • Patients must be eligible to receive the influenza vaccine
  • Patients must be able to provide written informed consent

Exclusion Criteria:

  • Patients unable to receive the influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillan-Barré syndrome, or other contraindication to the vaccine
  • Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474174

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Glenn Lesser Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01474174     History of Changes
Other Study ID Numbers: CCCWFU 98411, NCI-2011-03033
Study First Received: October 21, 2011
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Influenza, Human
Nervous System Neoplasms
Central Nervous System Neoplasms
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014