Overview

This trial is active, not recruiting.

Condition central nervous system neoplasm
Treatments trivalent influenza vaccine, laboratory biomarker analysis
Phase phase 1
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date November 2013
End date November 2014
Trial size 60 participants
Trial identifier NCT01941758, CCCWFU 97413, NCI-2013-01740, P30CA012197

Summary

This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Patients receive trivalent influenza vaccine on day 1.
trivalent influenza vaccine Flushield
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies
time frame: Baseline
Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies
time frame: Day 28

Secondary Outcomes

Measure
GMT
time frame: Up to 3 months
Seroconversion
time frame: Up to 3 months
Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40
time frame: Up to 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 willing to receive the Fluzone® high-dose seasonal influenza vaccine - Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document Exclusion Criteria: - Patients unable to receive the high-dose 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, Guillain-Barré syndrome, or other contraindication to the vaccine - Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study

Additional Information

Official title A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
Principal investigator Glenn Lesser
Description PRIMARY OBJECTIVES: I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors. SECONDARY OBJECTIVES: I. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination. II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination. III. To assess the seroprotection rates (i.e. post-vaccination titer >= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination. TERTIARY OBJECTIVES: I. To assess the relationship between serologic markers of immune function and response to high-dose vaccination. OUTLINE: Patients receive trivalent influenza vaccine on day 1. After completion of study, patients are followed up at 28 days and/or 3 months.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.