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Ovarian Cancer and Immune Response to Flu Vaccine

Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Remission

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00478387
Enrollment
37
Registered
2007-05-24
Start date
2006-10-31
Completion date
2011-06-30
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Advanced Ovarian and Primary Peritoneal Cancer in Remission

Brief summary

The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.

Interventions

BIOLOGICALThe current season's trivalent killed influenza vaccine

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. Time from completion of chemotherapy will be no more than 6 months. * If no clinical evidence of disease is present after diagnosis with Stage III or IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.

Exclusion criteria

* Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years. * Presence of active CNS disease. * Active bacterial, viral or fungal infections. * Chemotherapy, biologic therapy, or radiation therapy \< 4 weeks prior to study entry. * History of active autoimmunity or immunosuppression. * Use of immunosuppressive drugs within 4 weeks prior to study entry. Patients may receive chemotherapy or other immunosuppressive medications at the discretion of their physician during the subsequent year after influenza vaccination without exclusion from the study. * Patients with tumors of low malignant potential (borderline tumors) will not be eligible. * Prior influenza vaccination with the current vaccine. * History of serious sensitivity to eggs, or previous influenza vaccine. * Pregnant of breastfeeding subjects.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026