Ovarian Cancer and Immune Response to Flu Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00478387
First received: May 22, 2007
Last updated: January 15, 2008
Last verified: January 2008
  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: 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:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
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
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 ClinicalTrials.gov identifier: NCT00478387

Contacts
Contact: Mabet S de Lange, DVM 215-349-8939 mabet@mail.med.upenn.edu

Locations
United States, Pennsylvania
Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Christina S Chu, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Christina S Chu, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Christina Chu, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00478387     History of Changes
Other Study ID Numbers: 805443, UPCC 5806 (N01-A1-50024)
Study First Received: May 22, 2007
Last Updated: January 15, 2008
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
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 24, 2014