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OpenTrials
Completed

NCT Number: NCT00478387

Ovarian Cancer and Immune Response to Flu Vaccine

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The current season's trivalent killed influenza vaccine

Biological

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
May 24, 2007
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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