Ovarian Cancer Vaccine for Patients in Remission

Inclusion Criteria

• •Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
• •Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125.
• •Able and willing to undergo mononuclear cell collection.
• •Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
• •No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
• •No prior treatment with an investigational product within 30 days of enrollment.
• •Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
• •Serum creatinine ≤ 2 mg/dL.
• •Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal.
• •White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm\^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10\^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
• •Life expectancy of at least 12 months.
• •Eastern Cooperative Oncology Group Performance Status of 0-1.
• •All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1.
• •Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
• •Able to provide written informed consent.