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:

1. Presumptive Stage III/IV papillary serous or endometrioid ovarian cancer.
2. Per Amendment #8, treatment naïve, high risk ovarian cancer was no longer be stratified, but the following information was collected:

   1. Stage IV or suboptimal (\>1 cm residual) Stage III disease versus Stage III patients with optimal (≤1 cm residual) disease,
   2. CA-125 ≤10 U/ml versus CA-125 greater than 10 but less than or equal to 20 U/ml
   3. IP chemotherapy versus IV chemotherapy
3. Availability of "golf-ball" size 10-30 grams tissue at time of primary surgical debulking.
4. ECOG performance status (PS) 0-2 prior to tumor debulking laparotomy
5. 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:

1. 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 \< 30 days duration.
2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers were allowed if definitively resected.
3. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.
4. Any documented history of autoimmune disease with exception of Type 1 diabetes on stable insulin regimen, hypothyroidism on stable dose of replacement thyroid medication, vitiligo, or asthma not requiring systemic steroids.
5. Known HIV or chronic Hepatitis B or C infection.
6. Known history of allergies or sensitivities to gentamicin.
7. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or was not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Study Enrollment Inclusion Criteria

Patients were registered for inclusion in this study if they met all of the following criteria:

1. Histologically confirmed Stage III/IV papillary serous or endometrioid ovarian cancer.
2. Clinically defined CR (no cancer related symptoms, normal physical examination and CT scan abdomen/pelvis and CXR, and CA-125 ≤20 U/ml) following completion of primary surgical debulking. Patients enrolled must have completed at least 5 but no more than 6 cycles platinum/taxane adjuvant or interval debulking and chemotherapy (or chemotherapy as per recommendations of NCCN guidelines, category 1 (IP chemotherapy included)). (Patients who completed surgery/chemotherapy with a CA-125 \>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.)
3. Successful manufacturing of 4 vials of Vigil™ vaccine
4. Recovered from all clinically relevant toxicities related to prior protocol specific therapies (including neuropathy to ≤Grade 2).
5. ECOG performance status (PS) 0-1.
6. 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
7. Patients must have been off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
8. 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:

1. 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
2. Patients must not have received any other investigational agents within 4 weeks prior to Vigil™ vaccine administration.
3. Patients with history of brain metastases.
4. Patients with compromised pulmonary disease.
5. 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.
6. Prior splenectomy.
7. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
8. Kaposi's Sarcoma.
9. 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.
10. Patients with known HIV.
11. Patients with chronic Hepatitis B and C infection.
12. Patients with uncontrolled autoimmune diseases.