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ID trial | Trial title/country | Indication/clinical phase | Status/year approved-initiated | Gene(s) transferred | Vector used/administration route | Gene delivery |
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BE-0024 | A randomized, double blind, placebo-controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with high risk HPV infection. Belgium | Cervical intraepithelial neoplasia. Phase I | Open 2009-ND | (i) delE6 (ii) delE7 (iii) IL-2 | Vaccinia virus/ND | ND |
CN-0010 | Gendicine intratumoral injection combined with radiotherapy for advanced cervical carcinoma. China | Cervical carcinoma. Phase III | Open 2008-ND | p53 | Adenovirus/intramuscular | ND |
ES-0010 | A randomized, double blind, placebo-controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with high risk HPV infection. Spain | Cervical intraepithelial neoplasia. Phase I | Open 2009-ND | (i) delE6 (ii) delE7 (iii) IL-2 | Vaccinia virus/ND | ND |
FR-0032 | Phase II trial to assess efficacy of TG4001 (MVA-HPV-IL2) in patients with grade 2/3 cervical intra epithelial neoplasia (CIN 2/3) linked to HPV16 infection (protocol TH4001.07). France | CIN 2 and 3. Phase II | Open 2004-ND | (i) IL-2 (ii) HPV16 | Vaccinia virus/ND | ND |
MX-0001 | Clinical protocol. A phase II study. Efficacy of the gene therapy of the MVA E2 recombinant virus in the treatment of precancerous lesions (NIC I and NIC II) associated with infection of oncogenic human papillomavirus. Mexico | Cervical cancer. Phase II | Open ND-ND | ND | Adenovirus/ND | ND |
UK-0041 | Use of a recombinant vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK | Cervical intraepithelial neoplasia III. Phase I | Open 1996-ND | HPV E6 and E7 oncogenes | Poxvirus/ND | ND |
UK-0042 | Use of a recombinant vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK | Cervical intraepithelial neoplasia III. Phase I | Open 1997-ND | HPV E6 and E7 oncogenes | Poxvirus/ND | ND |
UK-0071 | A phase II, multicenter, double-blind, placebo-controlled, dose finding study of ZYC101a in the treatment of high-grade squamous intraepithelial lesions of the uterine cervix. UK | Anogenital neoplasia III. Phase II | Open 2001-ND | HPV E6 and E7 oncogenes | Naked plasmid DNA/ND | ND |
UK-0074 | TA-HPV recombinant vaccinia virus expressing the human papillomavirus 16 and 18 E6 and E7 proteins: application to amend currently approved protocol to add a clinical trial involving prime-boost strategy of TA-CIN administered in association with TA-HPV in high grade anogenital intraepithelial neoplasia (AGIN) patients (PB-HPV/01). UK | Cervical cancer. Phase I | Open 2001-ND | HPV E6 and E7 oncogenes | Vaccinia virus/ND | ND |
US-0592 | A phase 1 study to determine the safety and immunogenicity of vaccination with Listeria monocytogenes expressing human papilloma virus type 16 E7 for the treatment of progressive, recurrent, and advanced squamous cell cancer of the cervix. USA | Cervical cancer. Phase I | Open 2003-ND | HPV E7 oncogene | Listeria monocytogenes/intravenous | In vivo |
US-0595 | A phase I/II clinical trial of pNGVL4a-Sig/E7 (detox)/HSP70 for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). USA | Cervical cancer. Phases I and II | Open 2003-ND | HPV16 E7 oncogene | Naked plasmid DNA/intramuscular | In vivo |
US-0916 | Phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of human papillomavirus (HPV) DNA plasmid (VGX-3100) + electroporation (EP) in adult females with histological diagnosis of grade 2 or 3 cervical intraepithelial neoplasia (CIN). USA | Cervical cancer. Phase I | Open 2008-ND | (i) HPV16 E6 and E7 oncogenes (ii) HPV18 E6 and E7 oncogenes | Naked plasmid DNA/intramuscular | In vivo |
US-0928 | A phase I efficacy and safety study of HPV16-specific therapeutic DNA-r vaccinia vaccination in combination with topical imiquimod in patients with HPV16+ high grade cervical dysplasia (CIN3). USA | HPV16+ high-grade cervical dysplasia. Phase I | Open 2008-ND | (i) HPV16 + HPV18 (ii) E6 + E7 oncogenes | Naked plasmid DNA + Vaccinia virus/intramuscular | In vivo |
US-0958 | A randomized, double blind, placebo-controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu R05217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with high risk HPV infection. USA | Cervical intraepithelial neoplasia (CIN). Phase II | Open 2008-ND | (i) HPV E6 and E7 oncogenes (ii) IL-2 | Vaccinia virus/intramuscular | In vivo |
US-0984 | A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). USA | Cervical cancer. Phase I/II | Open 2009-ND | HPV16 E7 oncogene | Naked plasmid DNA/intramuscular | In vivo |
US-1040 | Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of a fourth dose of human papillomavirus (HPV) DNA plasmid (VGX-3100) + electroporation (EP) in adult females previously immunized with VGX-3100. USA | Cervical cancer. Phase I | Open 2010-ND | (i) HPV16 E6 and E7 oncogenes (ii) HPV18 E6 and E7 oncogenes | Naked plasmid DNA/intramuscular | In vivo |
US-1082 | A phase II evaluation of ADXS11-001 (NSC #752718, IND # 13,712) in the treatment of persistent or recurrent squamous or on-squamous cell carcinoma of the cervix. USA | Cervical cancer. Phase II | Open 2010-ND | HPV E7 oncogene | Listeria monocytogenes/intravenous | In vivo |
US-1093 | Phase II placebo-controlled study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) delivered IM followed by electroporation (Ep) with cellectra-5p for the treatment of biopsy-proven CIN 2/3 or CIN 3 with documented HPV 16 or 18. USA | Cervical cancer. Phase II | Open 2011-ND | (i) HPV16 E6-E7 fusion protein (ii) HPV18 E6-E7 fusion protein | Naked plasmid DNA/intramuscular | In vivo |
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