Salvage Ovarian FANG™ Vaccine + Bevacizumab

Inclusion criteria

• Histologically confirmed papillary serous or endometrioid ovarian cancer.
• Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CLPTL 105 but not otherwise qualifying.
• Recurrent cisplatinum resistant/refractory disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements with no intervening therapy.
• Successful manufacturing of 4 vials of Vigil™ vaccine.
• Recovered from all clinically relevant toxicities related to prior therapies.
• ECOG PS 0-2 prior to Vigil™ vaccine administration.
• Normal organ and marrow function as defined below:

• Absolute granulocyte count ≥1,500/mm3
• Absolute lymphocyte count ≥ 200/mm3
• Platelets ≥100,000/mm3
• Total bilirubin ≤1.5 x ULN
• AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
• Creatinine <1.5 mg/dL
• INR < 1.5
• Baseline blood pressure must be under 140/90
• Urine protein-to-creatinine ratio < 1.0 mg/dL.
• Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
• Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion criteria

• Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
• Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
• Patient must not have received any other investigational agents within 4 weeks prior to study entry.
• Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
• Patients with history of brain metastases.
• Patients with compromised pulmonary disease.
• Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
• Prior splenectomy.
• Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
• Kaposi's Sarcoma.
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
• History of Stroke/Transient Ischemic Attack
• Use of bleeding diathesis
• Use of anti-coagulants
• Patients with clinically significant cardiovascular disease including any of the following:

• Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block.
• Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
• Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
• New York Heart Association grade II or greater congestive heart failure.
• Serious cardiac arrhythmia requiring medication.
• Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit
• History of cerebrovascular accident within the past 6 months.
• No significant traumatic injury within the past 28 days.
• Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with known HIV.
• Patients with chronic Hepatitis B and C infection.
• Patients with uncontrolled autoimmune diseases.