Ovarian Cancer and Immune Response to Flu Vaccine

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478387
• Other study ID #: 805443
• Secondary ID: UPCC 5806 (N01-A
• Status: Completed
• Phase: N/A
• First received: May 22, 2007
• Last updated: October 3, 2016
• Start date: October 2006
• Est. completion date: June 2011

Study information

• Verified date: October 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• The current season's trivalent killed influenza vaccine

Locations

Country	Name	City	State
United States	Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,