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Safety of Active Immunotherapy in Subjects With Ovarian Cancer

NCT01456065 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-03-01

No results posted yet for this study

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.

Conditions

  • Ovarian Epithelial Cancer

Interventions

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.

Sponsors & Collaborators

  • Life Research Technologies GmbH

    lead OTHER

Principal Investigators

  • Martin Imhof, Dr. · Hospital Korneuburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Austria
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456065 on ClinicalTrials.gov