A Phase I, Open, Randomized, Study to Investigate the Safety of Active Immunotherapy With Fully Mature, TERT-mRNA and Survivin - Peptide Double Loaded Dendritic Cells (DCs) in Subjects With Advanced Epithelial Ovarian Cancer, Enrolled in the Study Within Twelve Weeks After Completing Primary Therapy
This is an uncontrolled, randomized, parallel-group, open-label phase I trial in patients
with advanced epithelial ovarian cancer. Patients were randomized into treatment group A
with weekly administration versus treatment group B with bi-weekly administration.
Patients in both treatment groups received a maximum of eight injections administered one by
one once a week for eight times for treatment group A and once in a fortnight for eight
times for treatment group B.
The treatment was completed within seven weeks for Arm A and within 14 weeks for Arm B.
Independently of the treatment arm they had been assigned to, all the patients were followed
for a period covering a total of 12 or 19 weeks or until disease progression. Safety
parameters (primary objective) and efficacy parameters (secondary objective) were recorded.
Upon completion of the treatment, one follow-up visit took place at week 12 (group A, only)
or 19 (group B, only).
To protect the patients' safety, the first six patients were treated as described below:
- The first patient was hospitalized and kept under medical observation for 72h after
administration of the first and second dose of the investigational product;
- After an observational period of 3 days following the second dose of the first patient,
the second and the third patient were administered the first dose of the
investigational product, hospitalized and kept under medical observation for 72h. The
two patients were treated simultaneously or consecutively;
- After an observational period of 3 days after the second dose to the first three
patients, an interim safety report was sent to the Ethics Committee;
- Additionally the next three patients were hospitalized, administered their first dose
of the vaccine and kept under medical observation for 72h. The three patients were
treated simultaneously or consecutively.
15 evaluable patients (which were randomized to one of the two treatment groups in
equal numbers) 5 study sites in Austria and Hungary
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters
from first treatment until up to 12 to 19 weeks
Martin Imhof, Dr.
Austria: Agency for Health and Food Safety