MCMRC IRB # 11-01
Randomized Phase II Trial of Adjuvant bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage IIIc Ovarian Cancer (Sponsor ID CL-PTL 105)
MCMRC IRB # 11-01
The purpose of this study is to test an investigational agent called FANG™ (bishRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine). A vaccine is a way of delivering a cancer protein in such a way that the immune system recognizes the protein as foreign and rejects or destroys any cells that have this protein.
The vaccine that will be given to the study participant is made from their cancer cells that are collected during a surgery, biopsy or drainage of fluid containing cancer cells. The vaccine that will be given to you is made from your cancer cells. Two genes are placed in your cancer cells. One blocks a protein produced by your cancer cells and the other turns on your immune system. Your modified cells are then treated with radiation to kill the cells. This mixture will then be made into a vaccine and given back to you.
- Histologically confirmed stage IIIc papillary serous or endometroid ovarian cancer.
- High risk ovarian cancer:
- Post-op/chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL; age ≥18 years OR
- Post-op/chemotherapy, pre-vaccine CA-125 0-10 U/mL AND
- Age > 40 years OR
- Residual disease following surgery > 0.1 cm (microscopic).
- Availability of “golf-ball” size ~ 30 grams tissue at time of primary surgical debulking.
- ECOG performance status (PS) 0-2 prior to tumor debulking laparotomy.
- ECOG performance status (PS) 0-1 prior to FANG™ vaccine administration.
- Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination.
- Patient must not have received any other investigational agents within 4 weeks prior to study entry.
- Patients with history of brain metastases.
- Patients with compromised pulmonary disease.
- Short term (<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day (maximum 10 mg/day) and bronchodialators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
Mary Crowley Cancer Research Center - Medical City (Dallas, TX), Palm Beach Cancer Institute (Palm Beach, FL),