Ovarian Cancer and Immune Response to Flu Vaccine

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00478387
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States