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


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Christina S Chu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

805443

NCT ID:

NCT00478387

Start Date:

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Advanced Ovarian and Primary Peritoneal Cancer in Remission
  • Ovarian Neoplasms

Name

Location

Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104