Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Chemotherapy for Patients With Recurrent Cisplatinum Sensitive 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 or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.
3. Recurrent cisplatinum-sensitive 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 after a 6 month period after platinum treatment.
4. Successful manufacturing of 4 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:
1. Absolute granulocyte count ≥ 1,500/mm3
2. Absolute lymphocyte count ≥ 200/mm3
3. Platelets ≥ 100,000/mm3
4. Total bilirubin ≤ 1.5 x ULN
5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN
6. Creatinine < 1.5 mg/dL
8. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
9. 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. Chemotherapy within 3 weeks prior
to vaccination. Steroid therapy within 1 week prior to vaccination.
2. Patient must not have received any other investigational agents within 4 weeks prior
to study entry.
3. Patients who require parenteral hydration of nutrition and have evidence of partial
bowel obstruction or perforation.
4. Patients with history of brain metastases.
5. Patients with compromised pulmonary disease.
6. Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day
(maximum 7.5 mg/day) and bronchodialators (inhaled steroids) are permitted; other
steroid regimens and/or immunosuppressives are excluded.
7. Prior splenectomy.
8. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ
cervix) unless in remission for ≥ 2 years.
9. Kaposi's Sarcoma.
10. Patients with peripheral neuropathy ≥2 (paclitaxel).
11. Uncontrolled infection or psychiatric illness/social situations that would limit
compliance with study requirements.
12. Patients with known HIV.
13. Patients with chronic Hepatitis B and C infection.
14. Patients with uncontrolled autoimmune diseases.