Cancer Care


Open-Label Phase II Trial of Adjuvant bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG(tm)) for High Risk Stage III/IV Ovarian Cancer
Principal Investigator (?)
Study Number
This is a Phase II open-label trial of maintenance FANG™ autologous tumor cell vaccine. Tumor will be harvested at the time of surgical debulking (standard of medical care). Subsequently, patients achieving clinical CR following primary surgical debulking and doublet chemotherapy will be stratified for i) surgical stage (Stage IV or suboptimal debulking (>1 cm residual) Stage III disease versus Stage III patients with optimal debulking (<1 cm residual)) and ii) post-op chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL versus 0≤10 U/ml. (Note: patients with Stage IIIc ovarian cancer will be additionally evaluated as a subset using descriptive statistics only). Patients will receive 1.0 x 10^7 cells / intradermal injection of gene transfected autologous tumor cells, FANG™, once a month for up to 12 doses as long as sufficient material is available. Enough harvested tissue to provide a minimum of 4 monthly injections will be required for entry into the study. Hematologic function, liver enzymes, renal function and electrolytes will be monitored monthly. Immune function analysis including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens will be monitored at (≤24 hours before) tissue harvest, ≤24 hours before the first cycle of chemotherapy (post debulking), ≤24 hours before the third cycle of chemotherapy (post debulking), baseline (screening), prior to FANG™ injection Months 2, 4, 6 and at EOT. The dates of the last dose of chemotherapy and the administration of FANG™ vaccine #1 will be recorded. Treatment will be continued until disease recurrence or exhaustion of the patient''s vaccine supply. If ≥ Grade 2 toxicity by NCI Common Toxicity Criteria (excluding Grade 2 fever ≤ 24 hours and Grade 2 and 3 injection site reactions) develops related to study treatment the vaccine dose will be reduced by 50% and continued on a monthly basis. If a single patient develops ≥ Grade 3 toxicity (other than injection site reaction) related to study treatment the trial will be placed on hold for reevaluation of design in discussion with FDA. During this hold, no new subjects will initiate dosing, but subjects already being dosed may continue dosing as scheduled if deemed clinically appropriate by the PI. 
Phase (?)
Phase III
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