Head and neck cancers, esophageal cancers, non-small cell lung cancers
Conditions
Interventions
Three cohorts (1.0 x 10E10 vp, 1.0 x 10E11 vp, 1.0 x 10E12 vp) of 3 subjects each are planned in a dose-escalation phase, and 3 additional subjects will be treated at the highest safe dose. Telomelysi
Sponsors
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed head and neck cancers, esophageal cancers and non-small cell lung cancers. -Locally invasive, surgically incurable advanced cancers. -Postoperative recurrent and surgically unresectable cancers. -Locally virus-injectable tumors. -Measurable and evaluable tumors. -Tumor area is more than 1 square centimeter and less than 25 square centimeters. -Patient who is expected to be alive for more than 12 weeks and Performance Status is 2 or less. -Patient who can give informed consent. -Patient who is not pregnant or nursing, or is using effective barrier birth control. -Patient who has intact function in bone marrow, liver and kidney.
Exclusion criteria
Exclusion criteria: -Patient who has uncontrolled infectious disease and/or severe disease. -Patient who received chemotherapy, laser irradiation or stent placement within 3 weeks (or used nitrosourea or mitomycin C within 6 weeks). -Patient who receives non-local adrenocortical steroid therapy. -Patient who participated in clinical study of other unapproved drug within 4 weeks. -Patient who has or had (has less than 2 years after diagnosis of) other malignant tumors except for head and neck and thoracic malignant tumors. -Patient who cannot be kept or followed in this study due to mental, familial, social, geographical reasons. -Patient who has past history of autogenous or allogenic organ and tissue transplantations. -Patient who has positive result in serological test for HIV1, HIV2, HBV and HCV. -Patient who are considered inadequate by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety -Spectrum and frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Change in tumor size -Progression free survival -Overall survival | — |
Countries
Japan
Contacts
Public ContactHiroshi Tazawa
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Gastroenterological Surgery
Outcome results
None listed