| B/BE/07/BVW1 | Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis | Humans | Gene coding for the human interleukin-10 (hIL-10) | 
          
                  | Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck | Humans | Wild-type p53 | 
          
                  | Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of | Humans | Wild-type p53 |