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Ovarian Cancer and Immune Response to Flu Vaccine

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: May 22, 2007
Last updated: October 3, 2016
Last verified: October 2016
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.

Condition Intervention
Ovarian Cancer
Biological: The current season's trivalent killed influenza vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Remission

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Enrollment: 37
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
To gather preliminary information regarding immune response following influenza vaccination via measurement of antibody in subjects with advanced ovarian and primary peritoneal cancer in remission..

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00478387

United States, Pennsylvania
Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Principal Investigator: Christina S Chu, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania Identifier: NCT00478387     History of Changes
Other Study ID Numbers: 805443  UPCC 5806 (N01-A1-50024) 
Study First Received: May 22, 2007
Last Updated: October 3, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Advanced Ovarian and Primary Peritoneal Cancer in Remission

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016