genetically modified mesenchymal stem cell theraopeutic against head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this research is to evaluate mtd, safety and efficacy of gx-051 after intratumoral injection in head and neck cancer patience.

the primary purpose of the study is to determine mtd(maximum tolerable dose) of gx-051 administered in tumor. the second purpose is to evaluate safety and efficacy of gx-051.

Eligibility criteria:
inclusion criteria: * are capable of understanding and complying with the requirements of the study and have signed the informed consent from (icf). * very advanced head and neck cancer aged more than 19. * longest distance of the tumor is bigger than 1 cm and capable of intratumoral injection. * baseline ecog performance status 0, 1 or 2. * have a life expectancy more than 6 months. exclusion criteria: * have no history of prior anticancer treatment. * female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year. * have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity. * patients currently receiving anticancer immuno-therapies patients who have received prior treatment with an stem cell therapy. * have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.). * have graft rejection reaction such as gvhd. * have immunodeficiency disease. * leukocytes\< 3.0 x109/l. * absolute neutrophil count \< 1.5x109/l. * platelet count \< 100 x 109/l. * have known positive test for hepatitis b surface antigen, hepatitis c antibody, and human immunodeficiency virus (hiv). * alanine aminotransferase (alt) \> 2.5xunl. * aspartate aminotransferase (ast)\> 2.5xunl. * total bilirubin\> unl. * have blood creatinine\> unl. * known allergy to il-12 or the excipient(s) of the study medication including fetal bovine serum. * second primary cancer metastatic brain tumor or meningioma. * have a tumor near a main artery. * uncontrolled hypertension. * uncontrolled diabetes uncontrolled (arrhythmia). * heart failure (more than nyha functional class ii); unstable coronary artery disease; myocardial infarction within 6 months. * child-pugh class c hepatic impairment. * severe renal impairment (creatinine clearance \< 30 ml/min) or on dialysis. * have active infection or history of recurrent infection. * patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * are considered ineligible by the investigator due to a mental disease or cns disease. * administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin c) before the beginning of study treatment. * patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening. * have participated in another clinical trial within 30 days prior to dosing.

Keywords: head and neck cancer gene therapy stem cell therapy immunotherappy