A Randomized, Open-Label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac) for Epithelial Ovarian Cancer Patients in First or Second 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).

- CA-125 ≤ upper limit of normal with a prior history of an elevated CA-125.

- Able and willing to undergo MNC 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/mm3. (These CBC 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.

Exclusion Criteria:

- Coexisting or other malignancies unless in complete remission for not less than 3
years. Does not include in situ carcinoma of the cervix or basal cell or squamous
cell carcinoma of the skin for which no restrictions apply, assuming they have been
adequately treated.

- Ovarian germ cell, sarcoma, or mixed Mullerian tumors.

- Prior cancer vaccine or cellular therapy.

- Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common
Terminology Criteria for Adverse Events criteria.

- Inability to provide informed consent or to comply with study-related procedures

- Concurrent systemic treatment with steroids or other immunosuppressive agents.

- Diagnosed immunodeficiency and/or autoimmune disorders.

- Myocardial infarction in the past 6 months and/or clinically significant heart
disease.

- Infection with human immunodeficient virus (HIV), Hepatitis B or C virus.

- Pregnant or breastfeeding.

- Evidence or history of central nervous system metastases.

- Full dose anticoagulation therapy administered within 7 days of leukapheresis
procedure.

- Hematopoietic growth factors administered within 14 days of enrollment.