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Ova 3
Evaluation of the Safety and Immunogenicity of a Peptide Vaccine in Patients with Epithelial Ovarian or Primary Peritoneal Carcinoma
Rationale:
The peptides used in this vaccine are synthetic copies of peptides associated with ovarian cancer tumor cells. In theory, vaccinating with these peptides in GM-CSF and Montanide will activate the immune system to recognized and kill ovarian tumor cells. GM-CSF is known to attract dendritic cells (a type of white blood cell which starts immune responses in the body) and to help dendritic cells grow. The adjuvant, Montanide, also helps to start an immune response by allowing for the slow release of GM-CSF.
Objectives:
The goal of this study is to determine if an experimental vaccine safely causes an immune response against ovarian cancer.
Eligibility:
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Diagnosed with epithelial ovarian or primary peritoneal carcinoma
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Age 18 years or older
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Completed primary therapy (surgery and chemotherapy used to treat newly diagnosed disease)
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Must express HLA-A1, -A2, or -A3
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GOG performance status of 0-2
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Patients having received chemotherapy, radiation, or immunotherapy in the previous four weeks or allergy shots, steroids, or growth factors in the previous two weeks are excluded
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Pregnant women are excluded
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Patients with class III or IV heart disease are excluded
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Patients with another cancer diagnoses are excluded unless the cancer is carcinoma in-situ of the breast or cervix, non-melanoma cancer of the skin, or any other cancer without distant metastasis that has been treated successfully without evidence of recurrence for over five years.
Outline:
Vaccines will be given over six weeks. The first three vaccinations will be administered at two different sites on the patient. After these are complete, the lymph node draining the vaccination site will be removed using a common procedure to see if the immune system is responding to the vaccine. Three additional vaccines will then be given only at the primary vaccination site.
For additional information regarding clinical trials for ovarian cancer, contact Melinh Jones at 434-243-9553 or mj9v@virginia.edu.
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