Central Nervous System Neoplasm Clinical Trial
Official title:
A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors
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
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.
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