NCT01456065

Safety of Active Immunotherapy in Subjects With Ovarian Cancer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Life Research Technologies GmbH · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ovarian Epithelial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Procure	The IMP (Investigational Medical Product) consists of 1.3\*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO (Dimethyl sulfoxide), solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial. 8 vial will be injected on weekly administration basis to the patient.
BIOLOGICAL	Procure	The IMP consists of 1.3\*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO, solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial, 8 vials will be injected into the patient on biweekly basis.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-10-20
• Last updated: 2013-03-01

Locations

5 sites across 2 countries: Austria, Hungary