Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Bevacizumab for Patients With Recurrent/Refractory Ovarian Cancer Participating in Study CL-PTL 105
1. Histologically confirmed papillary serous or endometroid ovarian cancer.
2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group
B) or patients with vaccine prepared for CL-PTL 105 but not otherwise qualifying.
3. 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.
4. Successful manufacturing of 5 vials of FANG™ vaccine.
5. Recovered from all clinically relevant toxicities related to prior therapies.
6. ECOG PS 0-2 prior to FANG™ vaccine administration.
7. 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
8. Urine protein-to-creatinine ratio < 1.0 mg/dL.
9. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
10. Ability to understand and the willingness to sign a written informed protocol
1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or
immunotherapy within 4 weeks prior to vaccination.
2. Major surgery within 6 weeks or minor surgery within 2 weeks of receiving
3. Patient must not have received any other investigational agents within 4 weeks prior
to study entry.
4. Patients who require parenteral hydration of nutrition and have evidence of partial
bowel obstruction or perforation.
5. Patients with history of brain metastases.
6. Patients with compromised pulmonary disease.
7. Short term (< 30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day
(maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other
steroid regimens and/or immunosuppressives are excluded.
8. Prior splenectomy.
9. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ
cervix) unless in remission for ≥ 2 years.
10. Kaposi's Sarcoma.
11. Patients with active bleeding or pathologic conditions that carry high risk of
bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major
12. Patients with clinically significant cardiovascular disease including any of the
- 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
- 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.
13. Uncontrolled infection or psychiatric illness/social situations that would limit
compliance with study requirements.
14. Patients with known HIV.
15. Patients with chronic Hepatitis B and C infection.
16. Patients with uncontrolled autoimmune diseases.