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

Phase

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

Pharmaceutical study code

TG4010.06

Information for the public

B/BE/02/B7 - Public information sheet (written by the notifier)

B/BE/02/B7 - Fiche d'information destinée au public (préparée par le notifiant)

B/BE/02/B7 – Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)

B/BE/02/B7 - Summary Notification Information Format (SNIF)

Public information presented according to the provisions of Directive 2001/18/EC

Information related to the decision procedure

B/BE/02/B7 - Advies van de a.i. Adviesraad voor Bioveiligheid / Avis du Conseil Consultatif de Biosécurité a.i.

09 August 2002: The Biosafety Advisory Council a.i. issues a positive advice for this trial (the advice is written in French and Dutch)

B/BE/02/B7 – Advice of the Regional Competent Authority

18 February 2002: The Regional Competent Authority issues a positive advice

B/BE/02/B7 - Decision of the Federal Ministry (FINAL DECISION)

22 October 2002: The Federal Ministry for Food chain safety and Environment gives a final decision (positive) for this trial.