Cancer Care


Randomized Phase II Trial of Adjuvant bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer
Principal Investigator (?)
Study Number
This is a Phase II 2:1 randomized study of adjuvant intradermal autologous FANG™ cancer
vaccine which is being expanded to women with Stage III/IV epithelial ovarian cancer who
attain a clinical complete response (including a post-treatment, prevaccination baseline
serum CA-125 level of ≤ 20 units/ml) after surgical cytoreduction and a total of six courses
of front-line (pre- and post or post-surgical) chemotherapy. The treatment arm will receive
FANG™ vaccine (Group A) at a dose of 1.0 x 10^7 cells/injection for minimum of 4 to a
maximum of 12 vaccinations (based on number of vaccine doses manufactured and patient
eligibility. The comparison arm (Group B) will be standard of care observational follow-up.
At recurrence, patients in Group B will be stratified into cisplatin sensitive and
-resistant groups and treated with second-line chemotherapy. The response rate and duration
of response to second-line therapy in patients with or without prior FANG™ will be compared.
Trial endpoints include time to recurrence (TTR), documentation of immune responses, and
correlation of immune response and clinical effect.
Phase (?)
Phase II
Sponsor (?)
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