Table 1.
HPV/HNC clinical trials according to www.clinicaltrials.gov
| Type | ClinicalTrials.gov | Agent(s) | ||
|---|---|---|---|---|
| Identifier | Phase | Trial Title | ||
| Vaccine containing | NCT01462838 | Phase I/II | Phase I/IIa study of immunization with a p16INK4a peptide combined with MONTANIDE ISA-51 VG in patients with advanced HPV-associated cancers | A vaccine with P16_37-63 with the vaccine adjuvant Montanide® ISA-51 VG |
| NCT00704041 | Phase I | A Phase 1 open label, dose escalation study to evaluate the effect of four doses of MAGE-A3/HPV 16 Trojan peptides 0001 and 0002 administered subcutaneously | A vaccine against MAGE-A3 and HPV-16 | |
| NCT00257738 | Phase I | A Phase 1 open label, dose escalation study to evaluate the effect of four doses of MAGE-A3/HPV 16 Trojan peptides 0001 and 0002 administered subcutaneously in combination with montanide and GM-CSF on immunological response, safety, tolerability, and preliminary efficacy in patients with squamous cell carcinoma of the head and neck | A vaccine against MAGE-A3 and HPV-16 | |
| NCT01493154 | Phase I | A Phase I clinical trial assessing the safety and feasibility of administration of pNGVL4a-CRT/E7(Detox) DNA vaccine using the intramuscular TriGridTM delivery system in combination with cyclophosphamide in HPV-16 associated head and neck cancer | pNGVL4a-CRT/E7 (detox) DNA vaccine in combination with cyclophosphamide | |
| Drug/radiation intervention | NCT01358097 | Phase I | Biomarkers of immune function as predictors of head and neck squamous cell carcinoma (HNSCC) in response to therapy | Radiation, chemotherapy, robotic surgery |
| NCT01384799 | Phase I | A phase I dose escalation study to investigate the safety and pharmacokinetics of intravenous CUDC-101 with concurrent cisplatin and radiation therapy in subjects with locally advanced human papillomavirus negative head and neck cancer | CUDC-101, cisplatin, radiation | |
| NCT01221753 | Phase II | A Phase II study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiotherapy using a modified radiation dose in patients with newly diagnosed HPV positive, locally advanced squamous cell carcinoma of the oropharynx | Docetaxel, cisplatin, 5-FU, carboplatin, cetuximab, radiation (intensity modulated radiation therapy) | |
| NCT01084083 | Phase II | A phase II trial of induction chemotherapy followed by cetuximab (Erbitux) with low dose versus standard dose IMRT in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx | Cetuximab, radiation (intensity modulated radiation therapy) | |
| NCT01302834 | Phase III | Phase III trial of radiotherapy plus cetuximab versus chemoradiotherapy in HPV-associated oropharynx cancer | Cetuximab, cisplatin, radiation | |
| NCT01268579 | Phase 0 | A pilot study to assess the pharmacodynamic effects of ribavirin in patients with tonsil and/or base of tongue squamous cell carcinoma | Ribavirin | |