A Trial of FANG™ Vaccine for Participants With Ovarian Cancer

Tissue Inclusion Criteria

Patients were eligible for tissue procurement for the Vigil™ vaccine manufacturing process if they met all of the following criteria:

• Presumptive Stage III/IV papillary serous or endometrioid ovarian cancer.
• Per Amendment #8, treatment naïve, high risk ovarian cancer was no longer be stratified, but the following information was collected:
• Stage IV or suboptimal (>1 cm residual) Stage III disease versus Stage III patients with optimal (≤1 cm residual) disease,
• CA-125 ≤10 U/ml versus CA-125 greater than 10 but less than or equal to 20 U/ml
• IP chemotherapy versus IV chemotherapy
• Availability of "golf-ball" size 10-30 grams tissue at time of primary surgical debulking.
• ECOG performance status (PS) 0-2 prior to tumor debulking laparotomy
• Ability to understand and the willingness to sign a written informed consent document for tissue harvest.

Tissue Exclusion Criteria

Patients who met any of the following criteria were not eligible for tissue procurement for the Vigil manufacturing:

• Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone or equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily) for 20 U/mL pre-registration had the option of being followed up to 2 months if serial CA-125 values continued to decrease at a rate of CA-125 decrease of ≥ 50% per month.)
• Successful manufacturing of 4 vials of Vigil™ vaccine
• Recovered from all clinically relevant toxicities related to prior protocol specific therapies (including neuropathy to ≤Grade 2).
• ECOG performance status (PS) 0-1.
• Normal organ and marrow function as defined below:

Absolute granulocyte count ≥ 1,500/mm3 Absolute lymphocyte count ≥ 200/mm3 Platelets ≥ 75,000/mm3 Total bilirubin ≤ 2 mg/dL AST(SGOT)/ALT(SGPT) ≤ 2x institutional upper limit of normal Creatinine < 1.5 mg/dL

• Patients must have been 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 document.

Study Enrollment Exclusion Criteria

Patients were excluded from this study if they met any of the following criteria:

• Surgery involving general anesthesia, radiotherapy, or immunotherapy within 4 weeks prior to randomization. Chemotherapy within 3 weeks prior to Vigil™ vaccine administration. Steroid therapy within 1 week prior to vaccine administration
• Patients must not have received any other investigational agents within 4 weeks prior to Vigil™ vaccine administration.
• 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) were permitted; patients requiring other steroid regimens and/or immunosuppressives at randomization were 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.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would have limited compliance with study requirements.
• Patients with known HIV.
• Patients with chronic Hepatitis B and C infection.
• Patients with uncontrolled autoimmune diseases.