Safety of Active Immunotherapy in Subjects With Ovarian Cancer

Phase 1

• Conditions: Ovarian Epithelial Cancer
• Interventions: Biological: Procure

• Registration Number: NCT01456065
• Lead Sponsor: Life Research Technologies GmbH

Brief Summary

The purpose of this study is to investigate the safety of the active immune therapy based on the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and Survivin-peptide double loaded DCs (Dendritic Cells) \[Procure®\] in patients with advanced ovarian cancer, enrolled into the study within twelve weeks after completing primary therapy.

Detailed Description

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccine weekly administration	Procure	-
Vaccine biweekly administration	Procure	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and clinical relevant deviations from Laboratory parameters	from first treatment until up to 12 to 19 weeks

Secondary Outcome Measures

Name	Time	Method
Number of circulating tumor cells in peripheral blood	from first treatment till up to 12 to 19 weeks	Circulating tumor cells (CTCs) will be quantified prior vaccination and follow up. CTCs will be enriched from peripheral blood and characterized by specific biomarkers. Quantitation of CTCs will provide information about the stage of a malignancy, onset of disease progression and response of therapy.
Immune monitoring - Number of autologous dendritic cells loaded with tumor specific antigens	from first treatment until treatment visit 7 up to 12 weeks	Immune monitoring will be done prior vaccination and during treatment. The immune reaction of the patients will be surveyed by determination of the frequency of specific markers for T-Cells, activated T-cells,B-cells,NK (Natural Killer)-cells, NKT (Natural Killer T)-cells.Quantification of these cells will be done by multicolour FACS (Florescence activated cell sorting). This method will be applied to determine the effects of dendritic cell treatment on the patients immune system.
time to progression (CA (Cancer Antigen)-125 and CT (Computer tomography)	from first treatment until up to 12 to 19 weeks
Overall survival	from first treatment until up to 96 weeks

Trial Locations

Locations (5)

Semelweis University; 🇭🇺 Budapest, Hungary

Hospital Korneuburg; 🇦🇹 Korneuburg, Austria

Hospital Landeskrankenhaus Innsbruck; 🇦🇹 Innsbruck, Austria

Hospital Barmherzigen Schwestern; 🇦🇹 Linz, Austria

National Oncology Institute; 🇭🇺 Budapest, Hungary