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Table 1: Approved gene therapy clinical trials in Belgium
(Authors: M. Sneyers and M. Goossens - Last revised:
July 28, 2010
)
Click on trial number for regulatory and clinical data on the trial
| Trial number (year of authorisation) |
Title |
|
B-GT/1 (1996) |
Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system |
| B-GT/2 (1997) | 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 surgery and radiation in the treatment of newly diagnosed, previously untreated gliogblastoma |
| B-GT/3 (1997) | 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 |
| B-GT/4 (1998) | 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 |
| B-GT/5 (1998) | 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, esophageal squamous cell carcinoma or bladder carcinoma |
| B-GT/6 (1998) | 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 |
| B-GT/7 (1998) | 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 cell carcinoma of the head and neck (SCCHN) |
| B-GT/8 (1998) | A phase II/III trial of chemotherapy alone versus chemotherapy plus SCH 58500 in newly diagnosed stage III ovarian and primary peritoneal cancer patients with superior or equal 0.5 cm and inferior or equal 2 cm residual disease following surgery |
| B-GT/9 (1998) | A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection |
| B-GT/10 (2000) | 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 with ALVAC-HIV (vCP-1452) and Remune or placebo while maintaining optimal therapeutic viral suppression |
| B-GT/11 (2002) | Randomized, multicenter, phase II study evaluating two doses of TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer |
| B-GT/12 (2002) | Randomized, multicenter, phase II study evaluating the clinical efficacy of TG4010(MVA-MUC-1-IL-2) in association with chemotherapy in patients with non small cell lung cancer |
| B-GT/13 (2002) | 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 methotrexate in 240 patients with refractory squamous cell carcinoma of the head and neck (SCCHN) |
| B-GT/14 (2002) | 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 the head and neck (SCCHN) |
| B-GT/15 (2002) | Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma |
| B-GT/16 (2003) | 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 |
| B-GT/17 (2003) | 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 |
| B-GT/18 (2004) | Phase I/II multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers |
| B-GT/19 (2005) | A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma |
| B-GT/20 (2006) | A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina |
| B-GT/21 (2008) | A phase 2a randomized, placebo-controlled, double-blind, multi-center dose escalation study, to evaluate the safety, tolerability, pharmacodynamics and efficacy of AG011, in subjects with moderately active ulcerative colitis |
| B-GT/22 (2008) | A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients. |
| B-GT/23 (2008) | Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants |
| B-GT/24 (2009) | A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 107 pfu (plaque forming units) of RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection |
| B-GT/25 (2010) | An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. |
|