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
F12188
Summary
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 (?)
Available at the following location(s)

Lebanon

View more details from ClinicalTrials.gov.

Contact Information

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