Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Low Burden Adenocarcinoma of the Ovary

Date de début de l'étude : 26 juillet 1999

INCLUSION CRITERIA: Patients must be 18 years of age or older. Histologic diagnosis of adenocarcinoma of the ovary. Tumor tissue availability for determination of p53 protein expression and genetic mutation (paraffin block, or fresh tissue). Immunohistochemical analysis of the tumor must demonstrate positive p53 staining. Patients should have ovarian cancer with marker only disease or patients with stage III, IV or recurrent who are NED post therapy. ECOG performance status of 1 or 0. Expected survival of more than 3 months. The patients should not have received chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination. And the patient should have recovered from all acute toxicities of previous treatment. Patients who received bone marrow transplantation within a year will not be eligible for the trial. Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities. Patients should have HLA-A2.1 haplotype. EXCLUSION CRITERIA: Any condition that does not fit with the eligibility criteria. Any of the following: Platelets less than 100K/mm(3) Creatinine greater than 2.0 mg/dl Serum Bilirubin greater than 2.0 mg/dl, SGOT, or SGPT greater than 4 times normal HIV or Hepatitis B or C (i.e. detectable HBS Antigen or HC Ab) since these conditions might have an effect on the immune system. Pregnant women or nursing mothers are ineligible since the effect of this investigational treatment on the health of the embryo is not known. Women with reproductive potential must have negative pregnancy test and must use adequate contraception. Patients with active ischemic heart disease (i.e. Class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy. Second malignancy (within the past 2 years) other than curatively treated carcinoma in-situ of cervix or basal cell carcinoma of the skin. These patients will be excluded for the possibility of the existence of a different mutation in the other primary malignancy. History of CNS metastases. Patients with underlying immune deficiency or history of autoimmune disease e.g. (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin). Patients with active infections requiring antibiotics. Patients requiring chronic suppressive antibiotics will be eligible for the trial. If, in the opinion of the principal or associate investigators, it is not in the best medical interest of the patient to enter this study, the patient will be ineligible.