Study title:
Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC)
EU record number:
B/BE/02/B7
Pharmaceutical study code:
TG4010.06
Company / Sponsor:
Transgene S.A.
Phase:
II
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Progressive metastatic renal cell carcinoma
Therapeutic approach:
Immunotherapy
Genetic modification:
sequences coding for the human MUC-1 antigen and IL-2
Method of transfer of nucleic acid of interest:
Attenuated Vaccinia Virus (Ankara Strain)
Administered biological material:
Recombinant Attenuated Vaccinia Virus
Route of administration:
Subcutaneous
Locations in Belgium:
Bruxelles: Cliniques Universitaires St Luc, Hôpital Erasme
Nr of subjects:
not specified (up to 32 patients in Europe)
Foreseen duration:
1 year
Type of procedure:
Contained use and Deliberate release
Current status:
Authorized
Information for the public
-
-
-
-
Public information presented according to the provisions of Directive 2001/18/EC
B/BE/02/B7 - Public information sheet (written by the notifier)Information related to the decision procedure
-
09 August 2002: The Biosafety Advisory Council a.i. issues a positive advice for this trial (the advice is written in French and Dutch)
-
18 February 2002: The Regional Competent Authority issues a positive advice
-
22 October 2002: The Federal Ministry for Food chain safety and Environment gives a final decision (positive) for this trial.