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Ovarian Cancer and Immune Response to Flu Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478387
First Posted: May 24, 2007
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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..
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478387


Locations
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)
Investigators
Principal Investigator: Christina S Chu, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00478387     History of Changes
Other Study ID Numbers: 805443
UPCC 5806 (N01-A1-50024)
First Submitted: May 22, 2007
First Posted: May 24, 2007
Last Update Posted: October 5, 2016
Last Verified: October 2016

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
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs