Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01740 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97413 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science (trivalent influenza vaccine) | Experimental | Patients receive trivalent influenza vaccine on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trivalent influenza vaccine | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline | |
| Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| GMT | Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine. | Up to 3 months |
| Seroconversion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical factors such as treatment, disease status, and use of glucocorticoids | Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors. | Up to 3 months |
| Serologic markers of immune function |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn Lesser | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| laboratory biomarker analysis | Other | Correlative studies |
|
Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.
| Up to 3 months |
| Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40 | Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate. | Up to 3 months |
To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used. |
| Up to 3 months |
| Response to vaccination | To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used. | Up to 3 months |
| Comprehensive Cancer Center of Wake Forest University |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided