| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine |
International AIDS Vaccine Initiative (IAVI) |
Humans |
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |
| B/BE/02/B7 |
Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) |
Transgene S.A. |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina |
Schering N.V./S.A. |
Humans |
human FGF-4 |
| B/BE/01/B7 |
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" |
Transgene S.A. |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
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 |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
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 |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
| B/BE/00/V15 |
Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v |
Merial |
Horses |
haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi |
Glaxo Wellcome |
Humans |
vCP-1452 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection |
Vion Pharmaceuticals, Inc. |
Humans |
Not relevant |
| B/BE/98/B6 |
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers |
Schering Plough NV/SA |
Humans |
wild-type p53 tumor suppressor gene |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous |
Rhone-Poulenc Rorer |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels |
Transgene |
Humans |
Muc-1 and Interleukine 2 (IL-2) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha |
Pasteur Mérieux Connaught |
Humans |
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles |
Schering Plough NV/SA |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of |
Genetic therapy, Inc., Sandoz Pharma, Ltd |
Humans |
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection |
Schering Plough NV/SA |
Humans |
Wild-type p53 |
