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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03033 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98411 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (vaccine therapy) | Patients receive trivalent influenza vaccine IM on day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trivalent influenza vaccine | Biological | Given IM |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months | |
| Relationship between a variety of clinical factors and seroconversion following influenza vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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patients with primary central nervous system turmors
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Lesser | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| 6 months |
| Relationship between serologic markers of immune function and response to vaccination | 6 months |