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

NCT ID: NCT01474174

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-07-31

Brief Summary

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

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.

Conditions

Central Nervous System Neoplasm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Supportive care (vaccine therapy)

Patients receive trivalent influenza vaccine IM on day 0.

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Given IM

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

trivalent influenza vaccine

Given IM

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

FluMist; Flushield; Fluvirin; Fluzone; Influenza Vaccine

Eligibility 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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Lesser

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2011-03033

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 98411

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00018422

Identifier Type: -

Identifier Source: org_study_id