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

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