Status:
UNKNOWN
rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors
Lead Sponsor:
Shenzhen SiBiono GeneTech Co.,Ltd
Conditions:
Advanced Oral and Maxillofacial Malignant Tumors
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination with surgery f...
Detailed Description
Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral ...
Eligibility Criteria
Inclusion
- Advanced stages of Oral and Maxillofacial malignant tumors (stage III and VI)
- At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
- Histologically confirmed Oral and Maxillofacial malignant tumors
- No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
- Age: 18-85 years old
- Expected to survive more 12 weeks
- ECOG:0-2
- Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
- Subject provided signed informed consent
Exclusion
- Hypersensitive to study drug
- Tumor(s) locate very close to important blood vessels and nerves, which affect injection
- With a coagulation and bleeding disorder
- With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
- Local infection close to injection site or systemic infection
- Pregnant or lactating
- Principle investigator consider not suitable -
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00902083
Start Date
June 1 2009
End Date
July 1 2012
Last Update
April 9 2012
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041