Neurofibromatosis type 1
Conditions
Interventions
Low dose group:Low-dose of recombinant Human Adenovirus Type 5 injection
High dose group:High-dose of recombinant Human Adenovirus Type 5 injection
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1: People or his/her legal guardian can understand the purpose of the study, and voluntarily participate and sign the informed consent 2: Patients aged 18-60, must have a confirmed diagnosis of neurofibromatosis type I-associated cutaneous neurofibroma by clinical diagnosis or genetic testing without the limitation of gender. 3: There are at least 2 trunk neurofibroma with a diameter of 20-50 millimeters on the skin. 4: Life expectancy greater than 2 year. 5: Blood test: Leukocytes=1.5×10^9/L, platelet=75×10.^9/L, hemoglobin=90g/L; Coagulation function : International normalized ratio ( INR ) or Prothrombin time ( PT ) < 1.5 × upper limit of normal ( ULN ), Activated partial thromboplastin time ( APTT ) = 1.5 × ULN. 6: Renal function: Serum creatinine=2.0 ULN, Creatinine clearance(CrCl) or the replacement of Glomerular filtration rate(GFR)=60ml/min; Liver function: Total bilirubin <1.5×ULN, AST/ALT<2.5 ULN.
Exclusion criteria
Exclusion criteria: 1: Treated with other therapies that have the impact on this study. 2: Participated in other clinical trials within 4 weeks before the first dose. 3: Patients with active infection or other systemic diseases such as mental disorders. 4: Patients with severe allergic constitution. 5: Used high dose glucocorticoid or other immunosuppressant within 1 month. 6: Patients can't tolerate MRI scans. 7: Women who are pregnant or preparing for pregnancy. 8: History of cardiovascular disease, such as: inadequately controlled HTN, history of CVA within 12 months, myocardial infarction or unstable angina within 12 months, New York heart association grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, serious vascular disease (e.g., aortic aneurysm, history of aortic dissection), and peripheral vascular disease. 9: Concurrent use of anti-coagulant drugs (not including prophylactic doses), history of coagulopathy, or evidence of bleeding diathesis or coagulopathy 10: Any history of symptomatic intracranial hemorrhage, or any history of spontaneous intracranial hemorrhage within 6 months. 11: Severe or unhealed wounds, ulcers or fractures. 12: History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months 13: Personal history of autoimmune coagulopathy, including idiopathic thrombocytopenia purpura (ITP) 14: HIV positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 15: The investigator think that there are any other subjects who may hinder compliance, hinder the completion of the study, damage the health of the subjects, or interfere with the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Probability of Adverse Event; | — |
Countries
P.R. China
Contacts
Public ContactQing-Feng Li
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed