Randomized Phase II Trial of Adjuvant bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG) for High Risk Stage III/IV Ovarian Cancer
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.
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.